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    Clinical Trial Results:
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327 (1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG

    Summary
    EudraCT number
    		 2010-023782-22
    Trial protocol
    		 ES   CZ   DE   HU   SK   BG  
    Global end of trial date
    09 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2016
    First version publication date
    06 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A9391010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01393639
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 East 42nd Street, New York, United States,
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy and safety of PF-04171327 (1, 5, 10 mg, 15 mg once daily) to 5 mg daily prednisone, 10 mg daily prednisone and placebo given over 8 weeks, in subjects with active rheumatoid arthritis (RA) on a stable background of methotrexate (MTX); Determine comparative therapeutic window of PF 04171327 using American College of Rheumatology (ACR) 20 responses and change from baseline in procollagen type 1 N terminal propeptide (P1NP) and urinary N telopeptide (UNTx)/ urinary creatinine (uCr), (primary set of biomarkers) ie, determining a dose, or a range of doses, in which there is sufficient efficacy on the ACR20 and minor changes in P1NP and UNTx/uCr.
    Protection of trial subjects
    The study was conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (International Conference on Harmonization 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). An independent review committee (IRC) reviewed accumulating safety data from this study at 25%, 50%, 75% and 100% completion of study. The IRC members were independent of study team. Based on these reviews, the IRC had the capacity to make recommendations that might impact the conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Mexico: 43
    Country: Number of subjects enrolled
    Romania: 8
    Country: Number of subjects enrolled
    Russian Federation: 92
    Country: Number of subjects enrolled
    Serbia: 4
    Country: Number of subjects enrolled
    Colombia: 15
    Country: Number of subjects enrolled
    United States: 16
    Country: Number of subjects enrolled
    Ukraine: 40
    Country: Number of subjects enrolled
    India: 4
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Slovakia: 23
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Bulgaria: 10
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 28
    Worldwide total number of subjects
    323
    EEA total number of subjects
    88
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    260
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multi-center, randomized, double-blind, parallel-group, active and placebo-controlled study randomized 323 participants in at 73 centers. An additional 34 centers had no screening activities, but received study medication; and an additional 17 centers had at least 1 participant screened, but did not randomize any participants.

    Pre-assignment
    Screening details
    		 Participants enrolled who had documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, had received methotrexate for at least 3 months to treat their rheumatoid arthritis, and were free of any signs or symptoms of infection.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This study is participant-, investigator- and sponsor-blinded. At the initiation of the study, the study site was instructed on the method for blind-breaking. This method was to be an electronic process in order to maintain documentation and prevent accidental unblinding. Blinding codes were only to be broken in an emergency situation for reasons of participant safety.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-04171327 1 mg
    Arm description
    		 Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04171327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug.

    Arm title
    		 PF-04171327 5 mg
    Arm description
    		 Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04171327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug.

    Arm title
    		 PF-04171327 10 mg
    Arm description
    		 Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04171327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug.

    Arm title
    		 PF-04171327 15 mg
    Arm description
    		 Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-04171327
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug.

    Arm title
    		 Prednisone 5 mg
    Arm description
    		 Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg capsule + 1 placebo tablet every 3 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off prednisone.

    Arm title
    		 Prednisone 10 mg
    Arm description
    		 Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off prednisone.

    Arm title
    		 Placebo
    Arm description
    		 Participants received 2 tablets of placebo QD every other day at weeks 9 and 10 dosing and every 3 days at weeks 11 and 12 dosing.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo QD until week 12.

    Number of subjects in period 1
    		PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Started
    45
    47
    45
    48
    45
    46
    47
    Completed
    42
    40
    44
    43
    44
    44
    39
    Not completed
    3
    7
    1
    5
    1
    2
    8
         Consent withdrawn by subject
    1
    1
    -
    -
    -
    -
    1
         Adverse Event
    2
    3
    1
    2
    -
    2
    3
         Not specified
    -
    2
    -
    2
    1
    -
    1
         Protocol Violation
    -
    -
    -
    1
    -
    -
    -
         Medication error without associated AE
    -
    -
    -
    -
    -
    -
    1
         Lost to follow-up
    -
    1
    -
    -
    -
    -
    1
         Lack of efficacy
    -
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-04171327 1 mg
    Reporting group description
    		 Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 5 mg
    Reporting group description
    		 Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 10 mg
    Reporting group description
    		 Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 15 mg
    Reporting group description
    		 Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    Prednisone 5 mg
    Reporting group description
    		 Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg capsule + 1 placebo tablet every 3 days.

    Reporting group title
    Prednisone 10 mg
    Reporting group description
    		 Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 2 tablets of placebo QD every other day at weeks 9 and 10 dosing and every 3 days at weeks 11 and 12 dosing.

    Reporting group values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo Total
    Number of subjects
    		 45 47 45 48 45 46 47 323
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 36 33 43 38 33 37 260
        From 65-84 years
    		 5 11 12 5 7 13 10 63
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.4 ( 14.2 ) 55.1 ( 12.1 ) 54.7 ( 13.1 ) 54 ( 11.1 ) 52.9 ( 11.2 ) 57.3 ( 10.7 ) 55.2 ( 13.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 33 38 34 37 39 41 37 259
        Male
    		 12 9 11 11 6 5 10 64

    End points

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    End points reporting groups
    Reporting group title
    PF-04171327 1 mg
    Reporting group description
    		 Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 5 mg
    Reporting group description
    		 Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 10 mg
    Reporting group description
    		 Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 15 mg
    Reporting group description
    		 Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    Prednisone 5 mg
    Reporting group description
    		 Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg capsule + 1 placebo tablet every 3 days.

    Reporting group title
    Prednisone 10 mg
    Reporting group description
    		 Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 2 tablets of placebo QD every other day at weeks 9 and 10 dosing and every 3 days at weeks 11 and 12 dosing.

    Primary: Proportion of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria at Week 8

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    End point title
    		 Proportion of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria at Week 8
    End point description
    ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Full Analysis Set (FAS) used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Percentage of participants
    47
    61
    69
    73
    51
    71
    37
    Statistical analysis title
    		 1. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    10
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 15
    Notes
    [1] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 2. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    24
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 31
    Notes
    [2] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 3. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    32
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 25
         upper limit
    		 39
    Notes
    [3] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 4. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    36
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 29
         upper limit
    		 43
    Notes
    [4] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 5. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    14
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 22
    Notes
    [5] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 6. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    34
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 27
         upper limit
    		 42
    Notes
    [6] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 7. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -24
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 -32
         upper limit
    		 -17
    Notes
    [7] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 8. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -10
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 -16
         upper limit
    		 -4
    Notes
    [8] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 9. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided.The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 4
    Notes
    [9] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.
    Statistical analysis title
    		 10. ACR20 response rates at Week 8
    Statistical analysis description
    Week 8 is the primary timepoint of interest. Bayesian 4 Parameter Emax Model Based Estimates are provided. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group. The total number of subjects used in fitting the Bayesian Emax model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1
    Confidence interval
         level
    		 60%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 8
    Notes
    [10] - Superiority criterion versus placebo: Lower bound of 60% credible interval >20%. Non-responder imputation was used to handle dropouts at Week 8.

    Primary: Percent change from Baseline 0 hour in procollagen type 1 N terminal propeptide (P1NP) at Week 8, 0 hour (comparisons to Prednisone 5 mg)

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    End point title
    		 Percent change from Baseline 0 hour in procollagen type 1 N terminal propeptide (P1NP) at Week 8, 0 hour (comparisons to Prednisone 5 mg)
    End point description
    Change from baseline in P1NP at week 8 is presented. FAS used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    42
    44
    43
    43
    44
    41
    Units: NG/ML
        least squares mean (standard error)
    -3.25 ( 5.5 )
    -11.6 ( 5.55 )
    -9.96 ( 5.49 )
    -16.63 ( 5.55 )
    -4.89 ( 5.55 )
    -20.14 ( 5.5 )
    14.19 ( 5.56 )
    Statistical analysis title
    		 1. P1NP at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 5 mg
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.75
         upper limit
    		 17.03
    Statistical analysis title
    		 2. P1NP at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 5 mg v PF-04171327 5 mg
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.16
         upper limit
    		 8.75
    Statistical analysis title
    		 3. P1NP at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 5 mg
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.45
         upper limit
    		 10.3
    Statistical analysis title
    		 4. P1NP at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 5 mg
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.19
         upper limit
    		 3.72

    Primary: Percent change from Baseline 0 hour in urinary N telopeptide/urinary creatinine (uNTx/uCr) at Week 8, 0 hour (comparisons to Prednisone 5 mg)

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    End point title
    		 Percent change from Baseline 0 hour in urinary N telopeptide/urinary creatinine (uNTx/uCr) at Week 8, 0 hour (comparisons to Prednisone 5 mg)
    End point description
    Change from baseline in uNTx/uCr at week 8 is presented. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    43
    42
    43
    43
    43
    43
    42
    Units: nM BCE/mM
        least squares mean (standard error)
    6.08 ( 5.83 )
    -3.78 ( 5.88 )
    6.96 ( 5.86 )
    15.57 ( 5.83 )
    2.74 ( 5.87 )
    -9.14 ( 5.83 )
    3.81 ( 5.88 )
    Statistical analysis title
    		 uNTx/uCr at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘number of subjects included in analysis’ displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 5 mg v PF-04171327 1 mg
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.92
         upper limit
    		 19.61
    Statistical analysis title
    		 uNTx/uCr at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘number of subjects included in analysis’ displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 5 mg v PF-04171327 5 mg
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.86
         upper limit
    		 9.81
    Statistical analysis title
    		 uNTx/uCr at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘number of subjects included in analysis’ displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 5 mg v PF-04171327 10 mg
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.11
         upper limit
    		 20.55
    Statistical analysis title
    		 uNTx/uCr at Week 8 (primary timepoint of interest)
    Statistical analysis description
    Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘number of subjects included in analysis’ displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in the FAS.
    Comparison groups
    Prednisone 5 mg v PF-04171327 15 mg
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.49
         upper limit
    		 29.15

    Secondary: ACR20 response rate at Weeks 2, 4, and 12 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 ACR20 response rate at Weeks 2, 4, and 12 (comparisons to placebo, and prednisone 10 mg)
    End point description
    ACR20 response: 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: participant and physician global assessments, pain, disability, and an acute phase reactant. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note: In the table below, n=number of ACR20 responders in the PF-04171327 1mg, 5mg, 10mg, 15mg, Prednisone 5mg and 10mg, and placebo groups respectively. In the table below, the values provided for the field "arithmetic mean" represent proportion of responders.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Response Rate
    arithmetic mean (standard error)
        Week 2 (n=14, 15, 18, 20, 13, 17, 9)
    31.82 ( 7.02 )
    32.61 ( 6.91 )
    40 ( 7.3 )
    42.55 ( 7.21 )
    28.89 ( 6.75 )
    36.96 ( 7.11 )
    20.45 ( 6.08 )
        Week 4 (n=14, 26, 30, 25, 22, 30, 18)
    31.11 ( 6.9 )
    55.32 ( 7.25 )
    66.67 ( 7.02 )
    53.19 ( 7.27 )
    48.89 ( 7.45 )
    65.22 ( 7.02 )
    40 ( 7.3 )
        Week 12 (n=16, 23, 25, 18, 22, 26, 15)
    35.56 ( 7.13 )
    48.94 ( 7.29 )
    55.56 ( 7.4 )
    38.3 ( 7.09 )
    48.89 ( 7.45 )
    56.52 ( 7.3 )
    33.33 ( 7.02 )
    Statistical analysis title
    		 1. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    11.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.84
         upper limit
    		 29.56
    Statistical analysis title
    		 2. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    12.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.88
         upper limit
    		 30.19
    Statistical analysis title
    		 3. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    19.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 38.17
    Statistical analysis title
    		 4. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    22.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.6
         upper limit
    		 40.58
    Statistical analysis title
    		 5. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.38
         upper limit
    		 26.25
    Statistical analysis title
    		 6. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    16.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.84
         upper limit
    		 34.84
    Statistical analysis title
    		 7. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.58
         upper limit
    		 10.8
    Statistical analysis title
    		 8. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    15.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.85
         upper limit
    		 35.49
    Statistical analysis title
    		 9. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    26.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.8
         upper limit
    		 46.53
    Statistical analysis title
    		 10. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    13.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.01
         upper limit
    		 33.4
    Statistical analysis title
    		 11. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.56
         upper limit
    		 29.33
    Statistical analysis title
    		 12. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    25.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.35
         upper limit
    		 45.07
    Statistical analysis title
    		 13. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.4
         upper limit
    		 21.85
    Statistical analysis title
    		 14. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.24
         upper limit
    		 35.45
    Statistical analysis title
    		 15. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    22.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 42.23
    Statistical analysis title
    		 16. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    4.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.6
         upper limit
    		 24.53
    Statistical analysis title
    		 17. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    15.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.51
         upper limit
    		 35.63
    Statistical analysis title
    		 18. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    23.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.31
         upper limit
    		 43.06
    Statistical analysis title
    		 19. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -5.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.73
         upper limit
    		 14.45
    Statistical analysis title
    		 20. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.79
         upper limit
    		 15.09
    Statistical analysis title
    		 21. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    3.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.94
         upper limit
    		 23.02
    Statistical analysis title
    		 22. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    5.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.26
         upper limit
    		 25.45
    Statistical analysis title
    		 23. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -34.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.4
         upper limit
    		 -14.8
    Statistical analysis title
    		 24. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -9.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.68
         upper limit
    		 9.88
    Statistical analysis title
    		 25. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.02
         upper limit
    		 20.92
    Statistical analysis title
    		 26. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -12.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.84
         upper limit
    		 7.79
    Statistical analysis title
    		 27. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -20.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.98
         upper limit
    		 -0.94
    Statistical analysis title
    		 28. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -7.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.82
         upper limit
    		 12.65
    Statistical analysis title
    		 29. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.36
         upper limit
    		 19.43
    Statistical analysis title
    		 30. ACR20 response rate at Weeks 2, 4, and 12
    Statistical analysis description
    Week 12 (taper period) results presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR20 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -18.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.18
         upper limit
    		 1.73

    Secondary: ACR50 response rate at Weeks 2, 4, 6, 8 and 12 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 ACR50 response rate at Weeks 2, 4, 6, 8 and 12 (comparisons to placebo, and prednisone 10 mg)
    End point description
    ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note: In the table below, n=number of ACR50 responders in the PF-04171327 1mg, 5mg, 10mg, 15mg, Prednisone 5mg and 10mg, and placebo groups respectively. In the table below, the values provided for the field "arithmetic mean" represent proportion of responders.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, and 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Response Rate
    arithmetic mean (standard error)
        Week 2 (n=2, 4, 4, 12, 1, 9, 3)
    4.55 ( 3.14 )
    8.7 ( 4.15 )
    8.89 ( 4.24 )
    25.53 ( 6.36 )
    2.22 ( 2.19 )
    19.57 ( 5.84 )
    6.82 ( 3.79 )
        Week 4 (n=4, 11, 16, 13, 5, 14, 5)
    8.89 ( 4.24 )
    23.4 ( 6.17 )
    35.56 ( 7.13 )
    27.66 ( 6.52 )
    11.11 ( 4.68 )
    30.43 ( 6.78 )
    11.11 ( 4.68 )
        Week 6 (n=5, 13, 18, 20, 11, 17, 7)
    11.11 ( 4.68 )
    27.66 ( 6.52 )
    40 ( 7.3 )
    42.55 ( 7.21 )
    24.44 ( 6.4 )
    36.96 ( 7.11 )
    15.56 ( 5.4 )
        Week 8 (n=10, 15, 22, 20, 12, 21, 6)
    22.22 ( 6.19 )
    31.91 ( 6.79 )
    48.89 ( 7.45 )
    42.55 ( 7.21 )
    26.67 ( 6.59 )
    45.65 ( 7.34 )
    13.33 ( 5.06 )
        Week 12 (n=8, 10, 11, 8, 12, 11, 8)
    17.78 ( 5.69 )
    21.28 ( 5.96 )
    24.44 ( 6.4 )
    17.02 ( 5.48 )
    26.67 ( 6.59 )
    23.91 ( 6.28 )
    17.78 ( 5.69 )
    Statistical analysis title
    		 1. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.93
         upper limit
    		 7.38
    Statistical analysis title
    		 2. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Placebo v PF-04171327 10 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.09
         upper limit
    		 13.23
    Statistical analysis title
    		 3. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    18.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.19
         upper limit
    		 33.23
    Statistical analysis title
    		 4. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.19
         upper limit
    		 4
    Statistical analysis title
    		 5. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    12.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.92
         upper limit
    		 26.41
    Statistical analysis title
    		 6. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.6
         upper limit
    		 10.16
    Statistical analysis title
    		 7. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    12.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 27.48
    Statistical analysis title
    		 8. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    24.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.71
         upper limit
    		 41.17
    Statistical analysis title
    		 9. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.98
         upper limit
    		 12.98
    Statistical analysis title
    		 10. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    19.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.16
         upper limit
    		 35.48
    Statistical analysis title
    		 11. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.46
         upper limit
    		 9.57
    Statistical analysis title
    		 12. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.49
         upper limit
    		 28.7
    Statistical analysis title
    		 13. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    24.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.63
         upper limit
    		 42.24
    Statistical analysis title
    		 14. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    26.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.33
         upper limit
    		 44.65
    Statistical analysis title
    		 15. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.53
         upper limit
    		 25.31
    Statistical analysis title
    		 16. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    21.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.88
         upper limit
    		 38.91
    Statistical analysis title
    		 17. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 24.57
    Statistical analysis title
    		 18. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    18.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.96
         upper limit
    		 35.2
    Statistical analysis title
    		 19. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    35.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.89
         upper limit
    		 53.21
    Statistical analysis title
    		 20. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    29.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.94
         upper limit
    		 46.49
    Statistical analysis title
    		 21. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    13.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.96
         upper limit
    		 29.63
    Statistical analysis title
    		 22. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    32.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.83
         upper limit
    		 49.8
    Statistical analysis title
    		 23. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.79
         upper limit
    		 15.79
    Statistical analysis title
    		 24. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    3.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.67
         upper limit
    		 19.67
    Statistical analysis title
    		 25. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.13
         upper limit
    		 23.47
    Statistical analysis title
    		 26. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.25
         upper limit
    		 14.74
    Statistical analysis title
    		 27. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.19
         upper limit
    		 25.96
    Statistical analysis title
    		 28. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 22.77
    Statistical analysis title
    		 29. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -15.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.03
         upper limit
    		 -2
    Statistical analysis title
    		 30. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -10.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.93
         upper limit
    		 3.19
    Statistical analysis title
    		 31. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -10.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.83
         upper limit
    		 3.48
    Statistical analysis title
    		 32. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    5.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.96
         upper limit
    		 22.9
    Statistical analysis title
    		 33. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -21.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.22
         upper limit
    		 -5.86
    Statistical analysis title
    		 34. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -7.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.01
         upper limit
    		 10.95
    Statistical analysis title
    		 35. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    5.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.17
         upper limit
    		 24.41
    Statistical analysis title
    		 36. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.22
         upper limit
    		 15.67
    Statistical analysis title
    		 37. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -25.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -42.54
         upper limit
    		 -9.14
    Statistical analysis title
    		 38. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -9.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.22
         upper limit
    		 9.62
    Statistical analysis title
    		 39. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    3.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.94
         upper limit
    		 23.02
    Statistical analysis title
    		 40. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    5.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.26
         upper limit
    		 25.45
    Statistical analysis title
    		 41. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -23.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -42.26
         upper limit
    		 -4.59
    Statistical analysis title
    		 42. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -13.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.35
         upper limit
    		 5.87
    Statistical analysis title
    		 43. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    3.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.26
         upper limit
    		 23.74
    Statistical analysis title
    		 44. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -3.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.27
         upper limit
    		 17.07
    Statistical analysis title
    		 45. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -6.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.77
         upper limit
    		 10.5
    Statistical analysis title
    		 46. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.63
         upper limit
    		 14.35
    Statistical analysis title
    		 47. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.06
         upper limit
    		 18.12
    Statistical analysis title
    		 48. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -6.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.24
         upper limit
    		 9.46
    Statistical analysis title
    		 49. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.15
         upper limit
    		 12.91
    Statistical analysis title
    		 50. ACR50 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR50 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    16.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 32.29

    Secondary: ACR70 response rate at Weeks 2, 4, 6, 8 and 12 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 ACR70 response rate at Weeks 2, 4, 6, 8 and 12 (comparisons to placebo, and prednisone 10 mg)
    End point description
    ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of following 5 criteria: participant and physician global assessments, pain, disability, and an acute phase reactant. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note: In the table below, n=number of ACR70 responders in the PF-04171327 1mg, 5mg, 10mg, 15mg, Prednisone 5mg and 10mg, and placebo groups respectively. In the table below, the values provided for the field "arithmetic mean" represent proportion of responders.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, and 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Response Rate
    arithmetic mean (standard error)
        Week 2 (n=0, 2, 1, 3, 1, 4, 0)
    0 ( 0 )
    4.35 ( 3 )
    2.22 ( 2.19 )
    6.38 ( 3.56 )
    2.22 ( 2.19 )
    8.7 ( 4.15 )
    0 ( 0 )
        Week 4 (n=0, 4, 7, 8, 2, 7, 0)
    0 ( 0 )
    8.51 ( 4.07 )
    15.56 ( 5.4 )
    17.02 ( 5.48 )
    4.44 ( 3.07 )
    15.22 ( 5.29 )
    0 ( 0 )
        Week 6 (n=1, 6, 6, 8, 3, 10, 2)
    2.22 ( 2.19 )
    12.77 ( 4.86 )
    13.33 ( 5.06 )
    17.02 ( 5.48 )
    6.67 ( 3.71 )
    21.74 ( 6.08 )
    4.44 ( 3.07 )
        Week 8 (4, 8, 12, 10, 3, 12, 5)
    8.89 ( 4.24 )
    17.02 ( 5.48 )
    26.67 ( 6.59 )
    21.28 ( 5.96 )
    6.67 ( 3.71 )
    26.09 ( 6.47 )
    11.11 ( 4.68 )
        Week 12 (n=3, 6, 3, 4, 5, 5 ,3)
    6.67 ( 3.71 )
    12.77 ( 4.86 )
    6.67 ( 3.71 )
    8.51 ( 4.07 )
    11.11 ( 4.68 )
    10.87 ( 4.58 )
    6.67 ( 3.71 )
    Statistical analysis title
    		 1. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 2. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    4.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.54
         upper limit
    		 10.24
    Statistical analysis title
    		 3. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 6.52
    Statistical analysis title
    		 4. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 13.37
    Statistical analysis title
    		 5. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for binomial proportions, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 6.52
    Statistical analysis title
    		 6. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 16.83
    Statistical analysis title
    		 7. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Statistical analysis title
    		 8. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 16.48
    Statistical analysis title
    		 9. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    15.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.96
         upper limit
    		 26.14
    Statistical analysis title
    		 10. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    17.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.27
         upper limit
    		 27.76
    Statistical analysis title
    		 11. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 10.46
    Statistical analysis title
    		 12. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    15.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.83
         upper limit
    		 25.59
    Statistical analysis title
    		 13. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.62
         upper limit
    		 5.18
    Statistical analysis title
    		 14. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.96
         upper limit
    		 19.6
    Statistical analysis title
    		 15. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    8.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.72
         upper limit
    		 20.5
    Statistical analysis title
    		 16. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    12.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 24.89
    Statistical analysis title
    		 17. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.23
         upper limit
    		 11.67
    Statistical analysis title
    		 18. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    17.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.94
         upper limit
    		 30.64
    Statistical analysis title
    		 19. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.6
         upper limit
    		 10.16
    Statistical analysis title
    		 20. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    5.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.22
         upper limit
    		 20.04
    Statistical analysis title
    		 21. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    15.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 31.4
    Statistical analysis title
    		 22. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    10.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 25.03
    Statistical analysis title
    		 23. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.16
         upper limit
    		 7.27
    Statistical analysis title
    		 24. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    14.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 30.63
    Statistical analysis title
    		 25. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 10.3
    Statistical analysis title
    		 26. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 18.1
    Statistical analysis title
    		 27. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 10.3
    Statistical analysis title
    		 28. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.96
         upper limit
    		 12.64
    Statistical analysis title
    		 29. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.27
         upper limit
    		 16.16
    Statistical analysis title
    		 30. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.37
         upper limit
    		 15.77
    Statistical analysis title
    		 31. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -8.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.83
         upper limit
    		 -0.55
    Statistical analysis title
    		 32. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.39
         upper limit
    		 5.7
    Statistical analysis title
    		 33. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -6.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.68
         upper limit
    		 2.73
    Statistical analysis title
    		 34. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 2 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.04
         upper limit
    		 8.41
    Statistical analysis title
    		 35. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -15.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.59
         upper limit
    		 -4.83
    Statistical analysis title
    		 36. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.79
         upper limit
    		 6.38
    Statistical analysis title
    		 37. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.49
         upper limit
    		 15.16
    Statistical analysis title
    		 38. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 4 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.13
         upper limit
    		 16.74
    Statistical analysis title
    		 39. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -19.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.19
         upper limit
    		 -6.84
    Statistical analysis title
    		 40. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    Prednisone 10 mg v PF-04171327 5 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -8.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.24
         upper limit
    		 6.29
    Statistical analysis title
    		 41. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.92
         upper limit
    		 7.1
    Statistical analysis title
    		 42. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 6 analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.76
         upper limit
    		 11.32
    Statistical analysis title
    		 43. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -17.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.36
         upper limit
    		 -2.02
    Statistical analysis title
    		 44. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.69
         upper limit
    		 7.56
    Statistical analysis title
    		 45. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.53
         upper limit
    		 18.68
    Statistical analysis title
    		 46. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 8 (primary timepoint of interest) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.07
         upper limit
    		 12.45
    Statistical analysis title
    		 47. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.77
         upper limit
    		 7.37
    Statistical analysis title
    		 48. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.21
         upper limit
    		 15
    Statistical analysis title
    		 49. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.77
         upper limit
    		 7.37
    Statistical analysis title
    		 50. ACR70 response rate at Weeks 2, 4, 6, 8 and 12
    Statistical analysis description
    Week 12 (taper period) analysis presented. Non-responder imputation was used to handle dropouts. Analyzed using normal approximation for difference in binomial proportions. Point estimates for ACR70 response rate, treatment differences and CIs for treatment differences were reported by week.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -2.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.38
         upper limit
    		 9.66

    Secondary: Change from Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant’s safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Joints
    least squares mean (standard error)
        Week 2
    -4.08 ( 0.74 )
    -5.55 ( 0.72 )
    -4.97 ( 0.73 )
    -5.65 ( 0.72 )
    -3.88 ( 0.73 )
    -5.38 ( 0.72 )
    -1.95 ( 0.74 )
        Week 4
    -5.97 ( 0.8 )
    -6.99 ( 0.79 )
    -7.01 ( 0.8 )
    -6.93 ( 0.79 )
    -5.79 ( 0.8 )
    -7.44 ( 0.79 )
    -4.16 ( 0.8 )
        Week 6
    -6.87 ( 0.87 )
    -8.83 ( 0.87 )
    -8.37 ( 0.87 )
    -8.31 ( 0.86 )
    -6.91 ( 0.87 )
    -8.75 ( 0.86 )
    -4.64 ( 0.87 )
        Week 8
    -7.06 ( 0.91 )
    -8.65 ( 0.92 )
    -9.46 ( 0.91 )
    -9.17 ( 0.91 )
    -7 ( 0.91 )
    -8.84 ( 0.9 )
    -4.27 ( 0.92 )
    Statistical analysis title
    		 1. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.19
         upper limit
    		 -0.07
    Statistical analysis title
    		 2. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.63
         upper limit
    		 -1.57
    Statistical analysis title
    		 3. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.06
         upper limit
    		 -0.97
    Statistical analysis title
    		 4. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.73
         upper limit
    		 -1.68
    Statistical analysis title
    		 5. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.97
         upper limit
    		 0.12
    Statistical analysis title
    		 6. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.46
         upper limit
    		 -1.39
    Statistical analysis title
    		 7. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.03
         upper limit
    		 0.42
    Statistical analysis title
    		 8. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.04
         upper limit
    		 -0.62
    Statistical analysis title
    		 9. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.07
         upper limit
    		 -0.64
    Statistical analysis title
    		 10. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.98
         upper limit
    		 -0.56
    Statistical analysis title
    		 11. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.85
         upper limit
    		 0.59
    Statistical analysis title
    		 12. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.48
         upper limit
    		 -1.06
    Statistical analysis title
    		 13. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.66
         upper limit
    		 0.2
    Statistical analysis title
    		 14. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.62
         upper limit
    		 -1.77
    Statistical analysis title
    		 15. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.15
         upper limit
    		 -1.31
    Statistical analysis title
    		 16. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.09
         upper limit
    		 -1.26
    Statistical analysis title
    		 17. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.69
         upper limit
    		 0.16
    Statistical analysis title
    		 18. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.52
         upper limit
    		 -1.7
    Statistical analysis title
    		 19. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.34
         upper limit
    		 -0.25
    Statistical analysis title
    		 20. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.93
         upper limit
    		 -1.83
    Statistical analysis title
    		 21. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.74
         upper limit
    		 -2.66
    Statistical analysis title
    		 22. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.43
         upper limit
    		 -2.36
    Statistical analysis title
    		 23. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.28
         upper limit
    		 -0.2
    Statistical analysis title
    		 24. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 -2.05
    Statistical analysis title
    		 25. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 3.33
    Statistical analysis title
    		 26. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.18
         upper limit
    		 1.84
    Statistical analysis title
    		 27. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 2.44
    Statistical analysis title
    		 28. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.27
         upper limit
    		 1.73
    Statistical analysis title
    		 29. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 3.68
    Statistical analysis title
    		 30. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.76
         upper limit
    		 2.65
    Statistical analysis title
    		 31. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.79
         upper limit
    		 2.63
    Statistical analysis title
    		 32. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 2.7
    Statistical analysis title
    		 33. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 4.29
    Statistical analysis title
    		 34. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.33
    Statistical analysis title
    		 35. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.03
         upper limit
    		 2.79
    Statistical analysis title
    		 36. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.97
         upper limit
    		 2.84
    Statistical analysis title
    		 37. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 4.3
    Statistical analysis title
    		 38. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 2.73
    Statistical analysis title
    		 39. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.14
         upper limit
    		 1.89
    Statistical analysis title
    		 40. Tender-Joint Counts at Weeks 2, 4, 6, 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.84
         upper limit
    		 2.19

    Secondary: Change from Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)
    End point description
    Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant’s safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    41
    44
    43
    44
    43
    41
    Units: Joints
        arithmetic mean (standard deviation)
    -6.25 ( 6.77 )
    -7.24 ( 6.13 )
    -6.16 ( 6.4 )
    -6.47 ( 7.54 )
    -7.07 ( 5.89 )
    -8.16 ( 4.66 )
    -5.59 ( 6.67 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant’s safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Joints
    least squares mean (standard error)
        Week 2
    -3.42 ( 0.62 )
    -4.7 ( 0.61 )
    -4.27 ( 0.62 )
    -5.36 ( 0.61 )
    -3.65 ( 0.62 )
    -5.04 ( 0.61 )
    -2.25 ( 0.62 )
        Week 4
    -5.54 ( 0.7 )
    -5.85 ( 0.71 )
    -5.94 ( 0.7 )
    -7 ( 0.7 )
    -5.75 ( 0.71 )
    -6.71 ( 0.7 )
    -3.87 ( 0.7 )
        Week 6
    -6.26 ( 0.69 )
    -6.9 ( 0.7 )
    -7.36 ( 0.69 )
    -7.68 ( 0.69 )
    -6.89 ( 0.69 )
    -8.02 ( 0.69 )
    -4.94 ( 0.69 )
        Week 8
    -6.5 ( 0.79 )
    -7.45 ( 0.8 )
    -7.95 ( 0.79 )
    -7.83 ( 0.79 )
    -6.9 ( 0.79 )
    -8.38 ( 0.78 )
    -4.51 ( 0.8 )
    Statistical analysis title
    		 1. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 0.56
    Statistical analysis title
    		 2. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.17
         upper limit
    		 -0.73
    Statistical analysis title
    		 3. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.76
         upper limit
    		 -0.29
    Statistical analysis title
    		 4. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.82
         upper limit
    		 -1.4
    Statistical analysis title
    		 5. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.13
         upper limit
    		 0.33
    Statistical analysis title
    		 6. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.52
         upper limit
    		 -1.07
    Statistical analysis title
    		 7. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.63
         upper limit
    		 0.29
    Statistical analysis title
    		 8. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.94
         upper limit
    		 -0.01
    Statistical analysis title
    		 9. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.03
         upper limit
    		 -0.11
    Statistical analysis title
    		 10. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.09
         upper limit
    		 -1.17
    Statistical analysis title
    		 11. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.85
         upper limit
    		 0.09
    Statistical analysis title
    		 12. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.79
         upper limit
    		 -0.88
    Statistical analysis title
    		 13. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.25
         upper limit
    		 0.6
    Statistical analysis title
    		 14. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 -0.04
    Statistical analysis title
    		 15. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.35
         upper limit
    		 -0.5
    Statistical analysis title
    		 16. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.66
         upper limit
    		 -0.83
    Statistical analysis title
    		 17. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.88
         upper limit
    		 -0.03
    Statistical analysis title
    		 18. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 -1.17
    Statistical analysis title
    		 19. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 0.21
    Statistical analysis title
    		 20. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.17
         upper limit
    		 -0.72
    Statistical analysis title
    		 21. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.65
         upper limit
    		 -1.23
    Statistical analysis title
    		 22. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.52
         upper limit
    		 -1.12
    Statistical analysis title
    		 23. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 -0.18
    Statistical analysis title
    		 24. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.07
         upper limit
    		 -1.68
    Statistical analysis title
    		 25. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 3.34
    Statistical analysis title
    		 26. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.36
         upper limit
    		 2.05
    Statistical analysis title
    		 27. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 2.48
    Statistical analysis title
    		 28. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.01
         upper limit
    		 1.38
    Statistical analysis title
    		 29. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 3.12
    Statistical analysis title
    		 30. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 2.82
    Statistical analysis title
    		 31. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 2.72
    Statistical analysis title
    		 32. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.24
         upper limit
    		 1.66
    Statistical analysis title
    		 33. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 3.67
    Statistical analysis title
    		 34. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 3.04
    Statistical analysis title
    		 35. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 2.57
    Statistical analysis title
    		 36. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 2.25
    Statistical analysis title
    		 37. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 4.07
    Statistical analysis title
    		 38. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 3.13
    Statistical analysis title
    		 39. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.76
         upper limit
    		 2.62
    Statistical analysis title
    		 40. Swollen-Joint Counts at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.63
         upper limit
    		 2.74

    Secondary: Change from Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)
    End point description
    Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant’s safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    41
    44
    43
    44
    43
    41
    Units: Joints
        arithmetic mean (standard deviation)
    -6.2 ( 6.21 )
    -5.98 ( 4.81 )
    -5.86 ( 6.17 )
    -5.58 ( 6.24 )
    -7.43 ( 5.82 )
    -7.07 ( 5.02 )
    -6.17 ( 5.48 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (comparisons to placebo and prednisone 10 mg)

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    End point title
    		 Change from Baseline in C-Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (comparisons to placebo and prednisone 10 mg)
    End point description
    The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: mg/L
    least squares mean (standard error)
        Week 2
    -7.29 ( 2.89 )
    -12.95 ( 2.82 )
    -13.73 ( 2.87 )
    -18.92 ( 2.78 )
    -8.25 ( 2.87 )
    -16.9 ( 2.86 )
    -2.8 ( 2.89 )
        Week 4
    -9.77 ( 2.77 )
    -14.33 ( 2.78 )
    -11.52 ( 2.81 )
    16.57 ( 2.75 )
    -3.92 ( 2.81 )
    -17.49 ( 2.76 )
    -6.35 ( 2.77 )
        Week 6
    -9.35 ( 2.51 )
    -16.16 ( 2.53 )
    -13.05 ( 2.49 )
    -13.81 ( 2.51 )
    -6.54 ( 2.52 )
    -16.85 ( 2.46 )
    -3.93 ( 2.53 )
        Week 8
    -7.29 ( 2.49 )
    -14.28 ( 2.52 )
    -14.86 ( 2.47 )
    -11.98 ( 2.49 )
    -7.23 ( 2.5 )
    -17.59 ( 2.44 )
    -4.19 ( 2.49 )
    Statistical analysis title
    		 1. CRP at Weeks 2, 4, 6 and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.52
         upper limit
    		 3.55
    Statistical analysis title
    		 2. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.1
         upper limit
    		 -2.2
    Statistical analysis title
    		 3. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.94
         upper limit
    		 -2.92
    Statistical analysis title
    		 4. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.01
         upper limit
    		 -8.24
    Statistical analysis title
    		 5. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.45
         upper limit
    		 2.56
    Statistical analysis title
    		 6. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.09
         upper limit
    		 -6.11
    Statistical analysis title
    		 7. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.13
         upper limit
    		 4.29
    Statistical analysis title
    		 8. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.7
         upper limit
    		 -0.26
    Statistical analysis title
    		 9. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.93
         upper limit
    		 2.59
    Statistical analysis title
    		 10. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.9
         upper limit
    		 -2.54
    Statistical analysis title
    		 11. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.32
         upper limit
    		 10.19
    Statistical analysis title
    		 12. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.83
         upper limit
    		 -3.45
    Statistical analysis title
    		 13. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.44
         upper limit
    		 1.59
    Statistical analysis title
    		 14. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.27
         upper limit
    		 -5.2
    Statistical analysis title
    		 15. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.11
         upper limit
    		 -2.14
    Statistical analysis title
    		 16. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.89
         upper limit
    		 -2.88
    Statistical analysis title
    		 17. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.63
         upper limit
    		 4.4
    Statistical analysis title
    		 18. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.88
         upper limit
    		 -5.98
    Statistical analysis title
    		 19. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.03
         upper limit
    		 3.83
    Statistical analysis title
    		 20. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.06
         upper limit
    		 -3.13
    Statistical analysis title
    		 21. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.57
         upper limit
    		 -3.77
    Statistical analysis title
    		 22. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.72
         upper limit
    		 -0.86
    Statistical analysis title
    		 23. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.98
         upper limit
    		 3.89
    Statistical analysis title
    		 24. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.27
         upper limit
    		 -6.54
    Statistical analysis title
    		 25. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.62
         upper limit
    		 17.61
    Statistical analysis title
    		 26. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.96
         upper limit
    		 11.85
    Statistical analysis title
    		 27. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 11.13
    Statistical analysis title
    		 28. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.86
         upper limit
    		 5.81
    Statistical analysis title
    		 29. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 15.42
    Statistical analysis title
    		 30. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.54
         upper limit
    		 10.87
    Statistical analysis title
    		 31. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 13.71
    Statistical analysis title
    		 32. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.75
         upper limit
    		 8.59
    Statistical analysis title
    		 33. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 14.43
    Statistical analysis title
    		 34. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.26
         upper limit
    		 7.64
    Statistical analysis title
    		 35. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.09
         upper limit
    		 10.7
    Statistical analysis title
    		 36. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.43
         upper limit
    		 17.18
    Statistical analysis title
    		 37. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.43
         upper limit
    		 17.18
    Statistical analysis title
    		 38. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.59
         upper limit
    		 10.22
    Statistical analysis title
    		 39. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 9.57
    Statistical analysis title
    		 40. CRP at Weeks 2, 4, 6, and 8
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.25
         upper limit
    		 12.48

    Secondary: Change from Baseline of CRP at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline of CRP at Week 12 (Descriptive Statistics)
    End point description
    The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    42
    39
    43
    42
    43
    42
    39
    Units: mg/L
        arithmetic mean (standard deviation)
    0.72 ( 27.4 )
    -6.24 ( 23.06 )
    -4.52 ( 20.35 )
    -0.64 ( 29.08 )
    -2.9 ( 16.1 )
    -9.39 ( 36.1 )
    -4.07 ( 22.1 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The subject’s response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: mm
    least squares mean (standard error)
        Week 2
    -10.24 ( 2.85 )
    -18.77 ( 2.79 )
    -24.72 ( 2.83 )
    -22.5 ( 2.77 )
    -10.04 ( 2.83 )
    -23.51 ( 2.84 )
    -10.61 ( 2.85 )
        Week 4
    -14.93 ( 3.21 )
    -24.04 ( 3.22 )
    -27.98 ( 3.24 )
    -23.14 ( 3.19 )
    -17.16 ( 3.24 )
    -28.31 ( 3.24 )
    -14.56 ( 3.21 )
        Week 6
    -18.77 ( 3.28 )
    -30.84 ( 3.28 )
    -35 ( 3.27 )
    -27.93 ( 3.24 )
    -23.07 ( 3.27 )
    -32.34 ( 3.27 )
    -18.55 ( 3.26 )
        Week 8
    -16.51 ( 3.49 )
    -29.08 ( 3.52 )
    -36.88 ( 3.5 )
    -31.32 ( 3.47 )
    -25.82 ( 3.5 )
    -34.6 ( 3.51 )
    -18.36 ( 3.51 )
    Statistical analysis title
    		 1. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.56
         upper limit
    		 8.31
    Statistical analysis title
    		 2. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.01
         upper limit
    		 -0.3
    Statistical analysis title
    		 3. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.01
         upper limit
    		 -6.2
    Statistical analysis title
    		 4. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.7
         upper limit
    		 -4.06
    Statistical analysis title
    		 5. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.33
         upper limit
    		 8.48
    Statistical analysis title
    		 6. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.8
         upper limit
    		 -4.98
    Statistical analysis title
    		 7. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.31
         upper limit
    		 8.58
    Statistical analysis title
    		 8. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.43
         upper limit
    		 -0.53
    Statistical analysis title
    		 9. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.39
         upper limit
    		 -4.44
    Statistical analysis title
    		 10. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.48
         upper limit
    		 0.33
    Statistical analysis title
    		 11. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.57
         upper limit
    		 6.38
    Statistical analysis title
    		 12. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.73
         upper limit
    		 -4.78
    Statistical analysis title
    		 13. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.32
         upper limit
    		 8.88
    Statistical analysis title
    		 14. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.39
         upper limit
    		 -3.17
    Statistical analysis title
    		 15. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.53
         upper limit
    		 -7.36
    Statistical analysis title
    		 16. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.42
         upper limit
    		 -0.34
    Statistical analysis title
    		 17.Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.61
         upper limit
    		 4.57
    Statistical analysis title
    		 18. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.87
         upper limit
    		 -4.69
    Statistical analysis title
    		 19. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 11.6
    Statistical analysis title
    		 20. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.51
         upper limit
    		 -0.93
    Statistical analysis title
    		 21. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.28
         upper limit
    		 -8.77
    Statistical analysis title
    		 22. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.67
         upper limit
    		 -3.25
    Statistical analysis title
    		 23. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.21
         upper limit
    		 2.3
    Statistical analysis title
    		 24. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26
         upper limit
    		 -6.48
    Statistical analysis title
    		 25. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.34
         upper limit
    		 21.2
    Statistical analysis title
    		 26. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.12
         upper limit
    		 12.59
    Statistical analysis title
    		 27. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 6.68
    Statistical analysis title
    		 28. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.79
         upper limit
    		 8.81
    Statistical analysis title
    		 29. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.39
         upper limit
    		 22.38
    Statistical analysis title
    		 30. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.73
         upper limit
    		 13.27
    Statistical analysis title
    		 31. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.68
         upper limit
    		 9.35
    Statistical analysis title
    		 32. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.77
         upper limit
    		 14.12
    Statistical analysis title
    		 33. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    13.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.44
         upper limit
    		 22.68
    Statistical analysis title
    		 34. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.64
         upper limit
    		 10.64
    Statistical analysis title
    		 35. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.76
         upper limit
    		 6.44
    Statistical analysis title
    		 36. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.65
         upper limit
    		 13.46
    Statistical analysis title
    		 37. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.34
         upper limit
    		 27.84
    Statistical analysis title
    		 38. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.27
         upper limit
    		 15.32
    Statistical analysis title
    		 39. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.03
         upper limit
    		 7.46
    Statistical analysis title
    		 40. Patient Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.42
         upper limit
    		 12.98

    Secondary: Change from Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
    End point description
    Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The subject’s response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    41
    44
    43
    44
    42
    41
    Units: mm
        arithmetic mean (standard deviation)
    -14.54 ( 27.33 )
    -22.26 ( 26.11 )
    -18.1 ( 25.35 )
    -16.74 ( 31.57 )
    -19.24 ( 29.32 )
    -25.29 ( 29.2 )
    -17.9 ( 23.14 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: mm
    least squares mean (standard error)
        Week 2
    -16.35 ( 2.53 )
    -21.74 ( 2.45 )
    -22.14 ( 2.48 )
    -25.21 ( 2.43 )
    -13.24 ( 2.48 )
    -22.8 ( 2.48 )
    -9.29 ( 2.5 )
        Week 4
    -22.25 ( 2.68 )
    -27.03 ( 2.64 )
    -30.72 ( 2.66 )
    -28.95 ( 2.62 )
    -20.94 ( 2.66 )
    -31.16 ( 2.66 )
    -15 ( 2.64 )
        Week 6
    -25.58 ( 2.68 )
    -32.54 ( 2.67 )
    -34.79 ( 2.66 )
    -32.79 ( 2.63 )
    -28.54 ( 2.66 )
    -33.92 ( 2.66 )
    -19.48 ( 2.65 )
        Week 8
    -26.24 ( 2.81 )
    -33.92 ( 2.82 )
    -38 ( 2.79 )
    -33.71 ( 2.77 )
    -29.25 ( 2.79 )
    -35.5 ( 2.79 )
    -21.52 ( 2.79 )
    Statistical analysis title
    		 1. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.07
         upper limit
    		 -0.06
    Statistical analysis title
    		 2. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.34
         upper limit
    		 -5.56
    Statistical analysis title
    		 3. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.79
         upper limit
    		 -5.91
    Statistical analysis title
    		 4. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.79
         upper limit
    		 -9.06
    Statistical analysis title
    		 5. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.89
         upper limit
    		 2.99
    Statistical analysis title
    		 6. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.44
         upper limit
    		 -6.57
    Statistical analysis title
    		 7. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.65
         upper limit
    		 0.16
    Statistical analysis title
    		 8. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.38
         upper limit
    		 -4.68
    Statistical analysis title
    		 9. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.1
         upper limit
    		 -8.35
    Statistical analysis title
    		 10. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.27
         upper limit
    		 -6.63
    Statistical analysis title
    		 11. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.31
         upper limit
    		 1.43
    Statistical analysis title
    		 12. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.54
         upper limit
    		 -8.79
    Statistical analysis title
    		 13. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 1.32
    Statistical analysis title
    		 14. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.46
         upper limit
    		 -5.65
    Statistical analysis title
    		 15. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.69
         upper limit
    		 -7.93
    Statistical analysis title
    		 16. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.66
         upper limit
    		 -5.96
    Statistical analysis title
    		 17. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.44
         upper limit
    		 -1.68
    Statistical analysis title
    		 18. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.82
         upper limit
    		 -7.06
    Statistical analysis title
    		 19. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.53
         upper limit
    		 3.09
    Statistical analysis title
    		 20. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.21
         upper limit
    		 -4.59
    Statistical analysis title
    		 21. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.25
         upper limit
    		 -8.71
    Statistical analysis title
    		 22. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.94
         upper limit
    		 -4.44
    Statistical analysis title
    		 23. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.5
         upper limit
    		 0.04
    Statistical analysis title
    		 24. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.75
         upper limit
    		 -6.21
    Statistical analysis title
    		 25. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 13.42
    Statistical analysis title
    		 26. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.81
         upper limit
    		 7.92
    Statistical analysis title
    		 27. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.25
         upper limit
    		 7.57
    Statistical analysis title
    		 28. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.26
         upper limit
    		 4.42
    Statistical analysis title
    		 29. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.48
         upper limit
    		 16.35
    Statistical analysis title
    		 30. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.24
         upper limit
    		 11.51
    Statistical analysis title
    		 31. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.96
         upper limit
    		 7.84
    Statistical analysis title
    		 32. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.14
         upper limit
    		 9.56
    Statistical analysis title
    		 33. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 15.77
    Statistical analysis title
    		 34. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.03
         upper limit
    		 8.8
    Statistical analysis title
    		 35. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.26
         upper limit
    		 6.52
    Statistical analysis title
    		 36. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.23
         upper limit
    		 8.49
    Statistical analysis title
    		 37. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 17.06
    Statistical analysis title
    		 38. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.23
         upper limit
    		 9.38
    Statistical analysis title
    		 39. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.27
         upper limit
    		 5.27
    Statistical analysis title
    		 40. Physician Global Assessment of Arthritis
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.95
         upper limit
    		 9.53

    Secondary: Change from Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
    End point description
    The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    43
    41
    44
    43
    44
    42
    40
    Units: mm
        arithmetic mean (standard deviation)
    -25 ( 21.57 )
    -28.56 ( 26.41 )
    -23.04 ( 22 )
    -24.3 ( 28.15 )
    -27.25 ( 23.71 )
    -27.25 ( 20.42 )
    -19.34 ( 27.21 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in pain VAS at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in pain VAS at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: mm
    least squares mean (standard error)
        Week 2
    -13.41 ( 2.88 )
    -17.4 ( 2.83 )
    -24.9 ( 2.86 )
    -22.86 ( 2.8 )
    -12.68 ( 2.86 )
    -24.59 ( 2.87 )
    -10.54 ( 2.88 )
        Week 4
    -15.55 ( 3.08 )
    -24.38 ( 3.09 )
    -29.7 ( 3.1 )
    -26.08 ( 3.05 )
    -20.26 ( 3.1 )
    -29.65 ( 3.11 )
    -14.28 ( 3.08 )
        Week 6
    -19.03 ( 3.33 )
    -29.16 ( 3.35 )
    -34.37 ( 3.33 )
    -30.15 ( 3.3 )
    -24.16 ( 3.33 )
    -34.69 ( 3.34 )
    -18.8 ( 3.32 )
        Week 8
    -18.95 ( 3.45 )
    -28.53 ( 3.5 )
    -37.96 ( 3.46 )
    -30.91 ( 3.43 )
    -25.86 ( 3.46 )
    -37.6 ( 3.47 )
    -18.26 ( 3.47 )
    Statistical analysis title
    		 1. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.89
         upper limit
    		 5.14
    Statistical analysis title
    		 2. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.8
         upper limit
    		 1.08
    Statistical analysis title
    		 3. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.34
         upper limit
    		 -6.38
    Statistical analysis title
    		 4. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.22
         upper limit
    		 -4.41
    Statistical analysis title
    		 5. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.12
         upper limit
    		 5.85
    Statistical analysis title
    		 6. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.05
         upper limit
    		 -6.04
    Statistical analysis title
    		 7. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.83
         upper limit
    		 7.3
    Statistical analysis title
    		 8. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.67
         upper limit
    		 -1.53
    Statistical analysis title
    		 9. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.01
         upper limit
    		 -6.82
    Statistical analysis title
    		 10. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.33
         upper limit
    		 -3.26
    Statistical analysis title
    		 11. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.57
         upper limit
    		 2.62
    Statistical analysis title
    		 12. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.98
         upper limit
    		 -6.76
    Statistical analysis title
    		 13. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.49
         upper limit
    		 9.03
    Statistical analysis title
    		 14. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.64
         upper limit
    		 -1.08
    Statistical analysis title
    		 15. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.83
         upper limit
    		 -6.32
    Statistical analysis title
    		 16. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -11.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.56
         upper limit
    		 -2.13
    Statistical analysis title
    		 17. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.61
         upper limit
    		 3.89
    Statistical analysis title
    		 18. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.15
         upper limit
    		 -6.61
    Statistical analysis title
    		 19. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.32
         upper limit
    		 8.94
    Statistical analysis title
    		 20. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.95
         upper limit
    		 -0.59
    Statistical analysis title
    		 21. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -19.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.34
         upper limit
    		 -10.06
    Statistical analysis title
    		 22. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.25
         upper limit
    		 -3.04
    Statistical analysis title
    		 23. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.24
         upper limit
    		 2.04
    Statistical analysis title
    		 24. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -19.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.99
         upper limit
    		 -9.68
    Statistical analysis title
    		 25. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    11.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.18
         upper limit
    		 19.16
    Statistical analysis title
    		 26. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 15.15
    Statistical analysis title
    		 27. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.28
         upper limit
    		 7.65
    Statistical analysis title
    		 28. Change from Baseline in pain VAS
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.14
         upper limit
    		 9.61
    Statistical analysis title
    		 29. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    14.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.51
         upper limit
    		 22.71
    Statistical analysis title
    		 30. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.38
         upper limit
    		 13.92
    Statistical analysis title
    		 31. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.68
         upper limit
    		 8.59
    Statistical analysis title
    		 32. Change from Baseline in pain VAS
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.99
         upper limit
    		 12.15
    Statistical analysis title
    		 33. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    15.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.38
         upper limit
    		 24.93
    Statistical analysis title
    		 34. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.81
         upper limit
    		 14.86
    Statistical analysis title
    		 35. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.97
         upper limit
    		 9.59
    Statistical analysis title
    		 36. Change from Baseline in pain VAS
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.69
         upper limit
    		 13.77
    Statistical analysis title
    		 37. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    18.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.03
         upper limit
    		 28.27
    Statistical analysis title
    		 38. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 18.78
    Statistical analysis title
    		 39. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 9.28
    Statistical analysis title
    		 40. Change from Baseline in pain VAS
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 16.29

    Secondary: Change from Baseline in Pain VAS at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in Pain VAS at Week 12 (Descriptive Statistics)
    End point description
    Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    40
    44
    43
    44
    42
    41
    Units: mm
        arithmetic mean (standard deviation)
    -17.86 ( 26.7 )
    -19.4 ( 29.04 )
    -18.23 ( 27.75 )
    -16.6 ( 30.5 )
    -21.52 ( 24.69 )
    -25.17 ( 29.6 )
    -16.3 ( 22.41 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Units on a scale
    least squares mean (standard error)
        Week 2
    -0.25 ( 0.06 )
    -0.34 ( 0.06 )
    -0.33 ( 0.06 )
    -0.41 ( 0.06 )
    -0.23 ( 0.06 )
    -0.41 ( 0.06 )
    -0.05 ( 0.06 )
        Week 4
    -0.26 ( 0.07 )
    -0.5 ( 0.07 )
    -0.43 ( 0.07 )
    -0.51 ( 0.07 )
    -0.34 ( 0.07 )
    -0.58 ( 0.07 )
    -0.14 ( 0.07 )
        Week 6
    -0.35 ( 0.07 )
    -0.6 ( 0.07 )
    -0.52 ( 0.07 )
    -0.56 ( 0.07 )
    -0.39 ( 0.07 )
    -0.68 ( 0.07 )
    -0.21 ( 0.07 )
        Week 8
    -0.26 ( 0.08 )
    -0.59 ( 0.08 )
    -0.6 ( 0.08 )
    -0.55 ( 0.08 )
    -0.5 ( 0.08 )
    -0.77 ( 0.08 )
    -0.19 ( 0.08 )
    Statistical analysis title
    		 1. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 -0.02
    Statistical analysis title
    		 2. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.11
    Statistical analysis title
    		 3. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.1
    Statistical analysis title
    		 4. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 -0.18
    Statistical analysis title
    		 5. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0
    Statistical analysis title
    		 6. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 -0.18
    Statistical analysis title
    		 7. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.31
         upper limit
    		 0.07
    Statistical analysis title
    		 8. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.17
    Statistical analysis title
    		 9. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 -0.09
    Statistical analysis title
    		 10. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.56
         upper limit
    		 -0.18
    Statistical analysis title
    		 11. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 -0.01
    Statistical analysis title
    		 12. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 -0.25
    Statistical analysis title
    		 13. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 0.05
    Statistical analysis title
    		 14. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.2
    Statistical analysis title
    		 15. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.51
         upper limit
    		 -0.12
    Statistical analysis title
    		 16. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.16
    Statistical analysis title
    		 17. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.01
    Statistical analysis title
    		 18. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 -0.27
    Statistical analysis title
    		 19. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.15
    Statistical analysis title
    		 20. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 -0.18
    Statistical analysis title
    		 21. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 -0.18
    Statistical analysis title
    		 22. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.14
    Statistical analysis title
    		 23. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.09
    Statistical analysis title
    		 24. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 -0.35
    Statistical analysis title
    		 25. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.34
    Statistical analysis title
    		 26. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.24
    Statistical analysis title
    		 27. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.25
    Statistical analysis title
    		 28. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.18
    Statistical analysis title
    		 29. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.51
    Statistical analysis title
    		 30. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.27
    Statistical analysis title
    		 31. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.34
    Statistical analysis title
    		 32. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.25
    Statistical analysis title
    		 33. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.52
    Statistical analysis title
    		 34. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.27
    Statistical analysis title
    		 35. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.35
    Statistical analysis title
    		 36. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.31
    Statistical analysis title
    		 37. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 0.73
    Statistical analysis title
    		 38. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.4
    Statistical analysis title
    		 39. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.4
    Statistical analysis title
    		 40. Change from Baseline in HAQ-DI
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.44

    Secondary: Change from Baseline in HAQ-DI at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in HAQ-DI at Week 12 (Descriptive Statistics)
    End point description
    Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    41
    44
    43
    44
    42
    41
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.28 ( 0.63 )
    -0.57 ( 0.65 )
    -0.37 ( 0.5 )
    -0.38 ( 0.5 )
    -0.52 ( 0.63 )
    -0.56 ( 0.59 )
    -0.26 ( 0.56 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in disease activity score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in disease activity score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF-04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Units on a scale
    least squares mean (standard error)
        Week 2
    -0.81 ( 0.13 )
    -1.15 ( 0.13 )
    -1.21 ( 0.13 )
    -1.51 ( 0.13 )
    -0.75 ( 0.13 )
    -1.23 ( 0.13 )
    -0.4 ( 0.13 )
        Week 4
    -1.19 ( 0.15 )
    -1.49 ( 0.15 )
    -1.71 ( 0.15 )
    -1.73 ( 0.15 )
    -1.01 ( 0.15 )
    -1.67 ( 0.15 )
    -0.76 ( 0.15 )
        Week 6
    -1.38 ( 0.16 )
    -1.81 ( 0.16 )
    -2.01 ( 0.16 )
    -1.99 ( 0.16 )
    -1.37 ( 0.16 )
    -1.98 ( 0.16 )
    -0.94 ( 0.16 )
        Week 8
    -1.44 ( 0.17 )
    -1.84 ( 0.17 )
    -2.22 ( 0.17 )
    -2.13 ( 0.17 )
    -1.42 ( 0.17 )
    -2.14 ( 0.17 )
    -0.93 ( 0.17 )
    Statistical analysis title
    		 1. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 -0.04
    Statistical analysis title
    		 2. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 -0.39
    Statistical analysis title
    		 3. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.18
         upper limit
    		 -0.44
    Statistical analysis title
    		 4. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 -0.74
    Statistical analysis title
    		 5. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Placebo v Prednisone 5 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.02
    Statistical analysis title
    		 6. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 -0.46
    Statistical analysis title
    		 7. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 0
    Statistical analysis title
    		 8. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.15
         upper limit
    		 -0.31
    Statistical analysis title
    		 9. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 -0.52
    Statistical analysis title
    		 10. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.39
         upper limit
    		 -0.54
    Statistical analysis title
    		 11. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 0.18
    Statistical analysis title
    		 12. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 -0.49
    Statistical analysis title
    		 13. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.02
    Statistical analysis title
    		 14. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 -0.41
    Statistical analysis title
    		 15. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.53
         upper limit
    		 -0.62
    Statistical analysis title
    		 16. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 -0.6
    Statistical analysis title
    		 17. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 0.03
    Statistical analysis title
    		 18. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.59
    Statistical analysis title
    		 19. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 -0.03
    Statistical analysis title
    		 20. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.43
    Statistical analysis title
    		 21. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 -0.8
    Statistical analysis title
    		 22. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 -0.72
    Statistical analysis title
    		 23. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 -0.01
    Statistical analysis title
    		 24. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 -0.73
    Statistical analysis title
    		 25. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.78
    Statistical analysis title
    		 26. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.44
    Statistical analysis title
    		 27. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.38
    Statistical analysis title
    		 28. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.65
         upper limit
    		 0.08
    Statistical analysis title
    		 29. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.91
    Statistical analysis title
    		 30. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.6
    Statistical analysis title
    		 31. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.38
    Statistical analysis title
    		 32. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.37
    Statistical analysis title
    		 33. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 1.06
    Statistical analysis title
    		 34. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.63
    Statistical analysis title
    		 35. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 0.42
    Statistical analysis title
    		 36. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.44
    Statistical analysis title
    		 37. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 1.18
    Statistical analysis title
    		 38. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.78
    Statistical analysis title
    		 39. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 0.4
    Statistical analysis title
    		 40. Change from Baseline in DAS 28-3 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.49

    Secondary: Change from Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)
    End point description
    DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    43
    41
    44
    41
    44
    43
    40
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.3 ( 1.21 )
    -1.37 ( 1.05 )
    -1.29 ( 1.14 )
    -1.25 ( 1.36 )
    -1.45 ( 1.05 )
    -1.62 ( 1 )
    -1.13 ( 1.08 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Units on a scale
    least squares mean (standard error)
        Week 2
    -0.88 ( 0.14 )
    -1.29 ( 0.14 )
    -1.45 ( 0.14 )
    -1.69 ( 0.14 )
    -0.82 ( 0.14 )
    -1.46 ( 0.14 )
    -0.52 ( 0.14 )
        Week 4
    -1.29 ( 0.16 )
    -1.68 ( 0.16 )
    -1.97 ( 0.16 )
    -1.9 ( 0.16 )
    -1.15 ( 0.16 )
    -1.92 ( 0.16 )
    -0.9 ( 0.16 )
        Week 6
    -1.51 ( 0.18 )
    -2.06 ( 0.18 )
    -2.32 ( 0.18 )
    -2.21 ( 0.18 )
    -1.56 ( 0.18 )
    -2.27 ( 0.18 )
    -1.12 ( 0.18 )
        Week 8
    -1.55 ( 0.19 )
    -2.07 ( 0.19 )
    -2.53 ( 0.19 )
    -2.38 ( 0.19 )
    -1.65 ( 0.19 )
    -2.44 ( 0.19 )
    -1.11 ( 0.19 )
    Statistical analysis title
    		 1. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 0.03
    Statistical analysis title
    		 2. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 -0.39
    Statistical analysis title
    		 3. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 -0.54
    Statistical analysis title
    		 4. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 -0.78
    Statistical analysis title
    		 5. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.09
    Statistical analysis title
    		 6. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 -0.55
    Statistical analysis title
    		 7. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 0.07
    Statistical analysis title
    		 8. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.23
         upper limit
    		 -0.32
    Statistical analysis title
    		 9. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.52
         upper limit
    		 -0.61
    Statistical analysis title
    		 10. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 -0.54
    Statistical analysis title
    		 11. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 0.21
    Statistical analysis title
    		 12. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 -0.57
    Statistical analysis title
    		 13. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 0.11
    Statistical analysis title
    		 14. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.45
    Statistical analysis title
    		 15. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.71
         upper limit
    		 -0.71
    Statistical analysis title
    		 16. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 -0.59
    Statistical analysis title
    		 17. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.95
         upper limit
    		 0.05
    Statistical analysis title
    		 18. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 -0.66
    Statistical analysis title
    		 19. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 0.08
    Statistical analysis title
    		 20. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 -0.44
    Statistical analysis title
    		 21. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.94
         upper limit
    		 -0.91
    Statistical analysis title
    		 22. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -0.76
    Statistical analysis title
    		 23. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 -0.03
    Statistical analysis title
    		 24. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 -0.81
    Statistical analysis title
    		 25. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 0.98
    Statistical analysis title
    		 26. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.56
    Statistical analysis title
    		 27. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.41
    Statistical analysis title
    		 28. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 2 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 0.16
    Statistical analysis title
    		 29. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 1.09
    Statistical analysis title
    		 30. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.7
    Statistical analysis title
    		 31. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.42
    Statistical analysis title
    		 32. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.48
    Statistical analysis title
    		 33. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.26
    Statistical analysis title
    		 34. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.7
    Statistical analysis title
    		 35. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 0.44
    Statistical analysis title
    		 36. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 6 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.56
    Statistical analysis title
    		 37. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.41
    Statistical analysis title
    		 38. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.89
    Statistical analysis title
    		 39. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v PF-04171327 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 0.42
    Statistical analysis title
    		 40. Change from Baseline in DAS28-4 CRP
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.57

    Secondary: Change from Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)
    End point description
    DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    43
    41
    44
    41
    44
    42
    40
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -1.39 ( 1.31 )
    -1.56 ( 1.17 )
    -1.42 ( 1.19 )
    -1.38 ( 1.47 )
    -1.59 ( 1.22 )
    -1.8 ( 1.14 )
    -1.29 ( 1.21 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36v2 mental component scores at Weeks 4 and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in SF-36v2 mental component scores at Weeks 4 and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness. FAS was used for this analysis. FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo).
    End point type
    Secondary
    End point timeframe
    Weeks 4 and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Units on a scale
    least squares mean (standard error)
        Week 4
    3.59 ( 1.28 )
    4.53 ( 1.26 )
    5.22 ( 1.3 )
    5.74 ( 1.25 )
    3.67 ( 1.29 )
    7.23 ( 1.29 )
    4.98 ( 1.28 )
        Week 8
    2.57 ( 1.39 )
    6.07 ( 1.41 )
    6.03 ( 1.4 )
    6.47 ( 1.39 )
    5.3 ( 1.4 )
    8.76 ( 1.4 )
    4.58 ( 1.39 )
    Statistical analysis title
    		 1. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.94
         upper limit
    		 2.17
    Statistical analysis title
    		 2. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.98
         upper limit
    		 3.08
    Statistical analysis title
    		 3. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Placebo v PF-04171327 10 mg
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.34
         upper limit
    		 3.82
    Statistical analysis title
    		 4. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.75
         upper limit
    		 4.28
    Statistical analysis title
    		 5. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.88
         upper limit
    		 2.27
    Statistical analysis title
    		 6. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.32
         upper limit
    		 5.82
    Statistical analysis title
    		 7. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.89
         upper limit
    		 1.87
    Statistical analysis title
    		 8. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.41
         upper limit
    		 5.4
    Statistical analysis title
    		 9. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.44
         upper limit
    		 5.34
    Statistical analysis title
    		 10. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.98
         upper limit
    		 5.76
    Statistical analysis title
    		 11. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.16
         upper limit
    		 4.61
    Statistical analysis title
    		 12. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 8.06
    Statistical analysis title
    		 13. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.21
         upper limit
    		 -0.06
    Statistical analysis title
    		 14. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.25
         upper limit
    		 0.85
    Statistical analysis title
    		 15. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.63
         upper limit
    		 1.6
    Statistical analysis title
    		 16. SF-36v2 mental component score
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.02
         upper limit
    		 2.05
    Statistical analysis title
    		 17. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.07
         upper limit
    		 -2.31
    Statistical analysis title
    		 18. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 1.23
    Statistical analysis title
    		 19. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.64
         upper limit
    		 1.18
    Statistical analysis title
    		 20. SF-36v2 mental component score
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.16
         upper limit
    		 1.58

    Secondary: Change from Baseline in SF-36v2 mental component scores at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in SF-36v2 mental component scores at Week 12 (Descriptive Statistics)
    End point description
    The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    41
    44
    43
    43
    42
    41
    Units: Units on a scale
        arithmetic mean (standard deviation)
    3.35 ( 11.99 )
    4.19 ( 9.19 )
    0.48 ( 8.97 )
    2.72 ( 10.67 )
    3.08 ( 12.91 )
    6.11 ( 12.9 )
    4.69 ( 10.72 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in SF-36v2 physical component scores at Weeks 4 and 8 (comparisons to placebo, and prednisone 10 mg)

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    End point title
    		 Change from Baseline in SF-36v2 physical component scores at Weeks 4 and 8 (comparisons to placebo, and prednisone 10 mg)
    End point description
    The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
    End point type
    Secondary
    End point timeframe
    Weeks 4 and 8
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    45
    47
    45
    48
    45
    46
    47
    Units: Units on a scale
    least squares mean (standard error)
        Week 4
    3.84 ( 0.92 )
    5 ( 0.91 )
    8.22 ( 0.93 )
    6.83 ( 0.9 )
    4.28 ( 0.93 )
    7.51 ( 0.93 )
    2.1 ( 0.92 )
        Week 8
    5.24 ( 1.03 )
    7.85 ( 1.04 )
    9.65 ( 1.03 )
    7.15 ( 1.02 )
    7.06 ( 1.03 )
    9.62 ( 1.03 )
    3.45 ( 1.03 )
    Statistical analysis title
    		 1. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 4.3
    Statistical analysis title
    		 2. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 5.45
    Statistical analysis title
    		 3. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.54
         upper limit
    		 8.7
    Statistical analysis title
    		 4. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.19
         upper limit
    		 7.26
    Statistical analysis title
    		 5. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 4.76
    Statistical analysis title
    		 6. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.83
         upper limit
    		 7.99
    Statistical analysis title
    		 7. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 4.65
    Statistical analysis title
    		 8. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Placebo
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.52
         upper limit
    		 7.28
    Statistical analysis title
    		 9. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.33
         upper limit
    		 9.07
    Statistical analysis title
    		 10. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 6.55
    Statistical analysis title
    		 11. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 5 mg v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 6.47
    Statistical analysis title
    		 12. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    Prednisone 10 mg v Placebo
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.29
         upper limit
    		 9.04
    Statistical analysis title
    		 13. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.27
         upper limit
    		 -1.09
    Statistical analysis title
    		 14. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.07
         upper limit
    		 0.05
    Statistical analysis title
    		 15. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 3.3
    Statistical analysis title
    		 16. SF-36v2 physical component scores
    Statistical analysis description
    Week 4 analysis presented. Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays the sum of the number of subjects randomized in each selected group . The total number of subjects used in fitting the mixed effects repeated measures model is the total number of subjects in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.23
         upper limit
    		 1.87
    Statistical analysis title
    		 17. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 1 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.26
         upper limit
    		 -1.5
    Statistical analysis title
    		 18. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 5 mg v Prednisone 10 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.65
         upper limit
    		 1.12
    Statistical analysis title
    		 19. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 10 mg v Prednisone 10 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.84
         upper limit
    		 2.91
    Statistical analysis title
    		 20. SF-36v2 physical component scores
    Statistical analysis description
    Week 8 (primary timepoint of interest) presented. Statistical analysis was performed using repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used. The field ‘Number of subjects included in analysis’ below displays sum of number of subjects randomized in each selected group. Total number of subjects used in fitting mixed effects repeated measures model is total number of subject in FAS.
    Comparison groups
    PF-04171327 15 mg v Prednisone 10 mg
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.33
         upper limit
    		 0.39

    Secondary: Change from Baseline in SF-36v2 physical component scores at Week 12 (Descriptive Statistics)

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    End point title
    		 Change from Baseline in SF-36v2 physical component scores at Week 12 (Descriptive Statistics)
    End point description
    The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
    End point type
    Secondary
    End point timeframe
    Week 12 (taper period)
    End point values
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Number of subjects analysed
    44
    41
    44
    43
    43
    42
    41
    Units: Units on a scale
        arithmetic mean (standard deviation)
    4.64 ( 8.21 )
    5.39 ( 7.05 )
    7.42 ( 8.56 )
    3.91 ( 7.16 )
    7.63 ( 7.95 )
    5.85 ( 7.32 )
    3.23 ( 4.8 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    13 weeks
    Adverse event reporting additional description
    All causality AEs and SAEs are included in this section. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    PF-04171327 1 mg
    Reporting group description
    		 Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 5 mg
    Reporting group description
    		 Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 10 mg
    Reporting group description
    		 Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    PF-04171327 15 mg
    Reporting group description
    		 Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days.

    Reporting group title
    Prednisone 5 mg
    Reporting group description
    		 Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg capsule + 1 placebo tablet every 3 days.

    Reporting group title
    Prednisone 10 mg
    Reporting group description
    		 Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo QD until week 12.

    Serious adverse events
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    2 / 45 (4.44%)
    2 / 48 (4.17%)
    0 / 45 (0.00%)
    2 / 46 (4.35%)
    2 / 47 (4.26%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioblastoma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Spinal compression fracture
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 PF-04171327 1 mg PF-04171327 5 mg PF-04171327 10 mg PF-04171327 15 mg Prednisone 5 mg Prednisone 10 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 45 (44.44%)
    18 / 47 (38.30%)
    22 / 45 (48.89%)
    16 / 48 (33.33%)
    16 / 45 (35.56%)
    19 / 46 (41.30%)
    16 / 47 (34.04%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 47 (6.38%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    3
    0
    1
    2
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    Varicose vein
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Surgical and medical procedures
    Knee operation
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Tooth extraction
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Chills
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    4
    0
    Drug ineffective
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    1
    Face oedema
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Local swelling
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    3
    2
    0
    2
    0
    Reproductive system and breast disorders
    Polymenorrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Respiratory disorder
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 47 (2.13%)
    4 / 45 (8.89%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    3 / 46 (6.52%)
    3 / 47 (6.38%)
         occurrences all number
    2
    2
    4
    0
    0
    4
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    2
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Soft tissue injury
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Spinal compression fracture
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Sinus bradycardia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Sinus tachycardia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    4 / 46 (8.70%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    12
    0
    Migraine
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Eosinophilia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Monocytosis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Eye disorders
    Astigmatism
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Cataract
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dry eye
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Presbyopia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Visual impairment
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    2 / 45 (4.44%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    1
    Aphthous stomatitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    2 / 45 (4.44%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    3
    2
    2
    0
    Food poisoning
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    2 / 45 (4.44%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    Oral discomfort
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Microalbuminuria
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Goitre
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 47 (2.13%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    5 / 46 (10.87%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    5
    0
    1
    10
    0
    Arthritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    3 / 45 (6.67%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    3
    1
    0
    0
    1
    Arthropathy
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    Muscle contracture
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    2 / 45 (4.44%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    0
    0
    2
    2
    1
    Pathological fracture
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    3 / 45 (6.67%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    2
    3
    0
    1
    Rheumatoid nodule
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Synovial cyst
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Tendonitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Abscess bacterial
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    1
    Candida infection
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 47 (6.38%)
    3 / 45 (6.67%)
    2 / 48 (4.17%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences all number
    1
    3
    3
    2
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    3 / 45 (6.67%)
    2 / 48 (4.17%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    3
    2
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 47 (2.13%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 47 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Polydipsia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 47 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Aug 2011
    Amendment 1 provided for additional liver test monitoring and follow ups. It also clarified that the Data Monitoring Committee for this study was an IRC.
    13 Mar 2012
    Amendment 2 provided for the inclusion of women of childbearing potential and the monitoring of precautionary renal safety parameters. In addition, more details were provided on the planned statistical analysis of study endpoints.
    15 Jun 2012
    Amendment 3 was only applicable to study sites in India because of a request by the Drugs Controller General of India, which added an upper age limit for enrollment of subjects of 60 years of age or younger. This requirement was not based on any specific safety concerns; however, it was intended to ensure adequate understanding of protocol specific procedures and demands of study participation such as multiple blood draws, repeated clinic visits, etc. This amendment was to be submitted to the institutional review board (IRB) or IEC responsible for this study at the sites in India via a letter of administration. This letter was to be submitted for information only. No change in the overall conduct of the study based on this letter was to occur.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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