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    Clinical Trial Results:
    A Double -Blind, Randomized, Placebo-Controlled, Parallel, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects With Moderate to Severe Ulcerative Colitis (Turandot)

    Summary
    EudraCT number
    		 2012-002030-37
    Trial protocol
    		 BE   NL   IT   PL   SK   HU   CZ   DE   SE   AT   ES   BG   HR  
    Global end of trial date
    04 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2016
    First version publication date
    03 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A7281009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01620255
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.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
    04 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to characterize the dose response and efficacy of PF-00547659 in inducing clinical remission based upon Mayo Score in subjects with moderate to severe ulcerative colitis (UC).
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed; in particular, those affording greater protection to the safety of study subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2012
    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
    Australia: 18
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Canada: 18
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 23
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Serbia: 15
    Country: Number of subjects enrolled
    Slovakia: 13
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United States: 100
    Worldwide total number of subjects
    357
    EEA total number of subjects
    168
    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)
    354
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted at 21 countries. Subjects were males/females between the ages of 18 and 65 years, inclusive, at the time of informed consent. Subjects were to have a diagnosis of UC for more than or equal to (>=) 3 months and a flexible sigmoidoscopy/colonoscopy indicative of active UC during Screening.

    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
    The subjects, investigators, and Sponsor were blinded to randomized study treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo (pbo) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on the anterolateral right or left thighs

    Arm title
    		 PF-00547659 7.5 mg
    Arm description
    		 Subjects received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    PF-00547659
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on anterolateral right or left thighs

    Arm title
    		 PF-00547659 22.5 mg
    Arm description
    		 Subjects received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    PF-00547659
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on anterolateral right or left thighs

    Arm title
    		 PF-00547659 75 mg
    Arm description
    		 Subjects received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    PF-00547659
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on anterolateral right or left thighs

    Arm title
    		 PF-00547659 225 mg
    Arm description
    		 Subjects received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-00547659
    Investigational medicinal product code
    PF-00547659
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection on anterolateral right or left thighs

    Number of subjects in period 1
    		Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Started
    73
    71
    72
    71
    70
    Completed
    69
    65
    70
    68
    64
    Not completed
    4
    6
    2
    3
    6
         Consent withdrawn by subject
    4
    1
    1
    2
    4
         Adverse event, non-fatal
    -
    4
    -
    1
    1
         Withdrawn at discretion of investigator
    -
    -
    -
    -
    1
         Non-compliance
    -
    1
    -
    -
    -
         Subject underwent fecal transplant
    -
    -
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (pbo) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 7.5 mg
    Reporting group description
    		 Subjects received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 22.5 mg
    Reporting group description
    		 Subjects received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 75 mg
    Reporting group description
    		 Subjects received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 225 mg
    Reporting group description
    		 Subjects received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg Total
    Number of subjects
    		 73 71 72 71 70 357
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 72 71 71 71 69 354
        From 65-84 years
    		 1 0 1 0 1 3
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.6 ( 12.7 ) 41.3 ( 12.5 ) 42.1 ( 14.7 ) 37.7 ( 12.4 ) 41.3 ( 13.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 29 32 26 34 28 149
        Male
    		 44 39 46 37 42 208

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (pbo) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 7.5 mg
    Reporting group description
    		 Subjects received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 22.5 mg
    Reporting group description
    		 Subjects received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 75 mg
    Reporting group description
    		 Subjects received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 225 mg
    Reporting group description
    		 Subjects received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Primary: Percentage of subjects in clinical remission at Week 12

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    End point title
    		 Percentage of subjects in clinical remission at Week 12
    End point description
    Clinical remission was defined as a Total Mayo Score of less than or equal to (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The MayoScore is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percentage of subjects
    number (confidence interval 90%)
        Centrally read (CR)
    2.7 (0.7 to 7.6)
    11.3 (5.7 to 18.8)
    16.7 (9.9 to 25.4)
    15.5 (9.5 to 23.6)
    5.7 (2.5 to 12.5)
        Locally read (LR)
    5.5 (2.4 to 12)
    14.1 (7.8 to 22)
    23.6 (15.6 to 33.1)
    18.3 (11.9 to 27.1)
    12.9 (7.3 to 21.1)
    Statistical analysis title
    		 PF-00547659 7.5 mg versus (vs) placebo, CR
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0213 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.019
         upper limit
    		 0.14
    Notes
    [1] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0025 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.128
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.056
         upper limit
    		 0.199
    Notes
    [2] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.118
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.048
         upper limit
    		 0.188
    Notes
    [3] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1803 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.026
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.012
         upper limit
    		 0.064
    Notes
    [4] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0582 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.002
         upper limit
    		 0.159
    Notes
    [5] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0014 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.178
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.083
         upper limit
    		 0.272
    Notes
    [6] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0125 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.122
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.036
         upper limit
    		 0.208
    Notes
    [7] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0927 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.066
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.009
         upper limit
    		 0.142
    Notes
    [8] - 1-sided p-value

    Secondary: Percentage of subjects with clinical response at Week 12

    		 Close Top of page
    End point title
    		 Percentage of subjects with clinical response at Week 12
    End point description
    Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. "n" signifies the number of subjects evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percentage of subjects
    number (confidence interval 90%)
        Centrally read (CR) (n=73,71,72,71,70)
    28.8 (20.2 to 37.8)
    38 (28.4 to 47.6)
    54.2 (44.2 to 64.2)
    45.1 (35 to 55.3)
    50 (39.6 to 60.4)
        Locally read (LR) (n=73,70,72,70,70)
    32.9 (24.2 to 42.3)
    38.6 (28.8 to 48.1)
    54.2 (44.2 to 64.2)
    48.6 (38.2 to 59)
    51.4 (41 to 61.8)
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1379 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.089
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.037
         upper limit
    		 0.214
    Notes
    [9] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0011 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.254
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.121
         upper limit
    		 0.388
    Notes
    [10] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0239 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.163
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.032
         upper limit
    		 0.293
    Notes
    [11] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0052 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.213
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 0.347
    Notes
    [12] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2617 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.056
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.075
         upper limit
    		 0.186
    Notes
    [13] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0058 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.212
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.077
         upper limit
    		 0.347
    Notes
    [14] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0326 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.156
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.022
         upper limit
    		 0.29
    Notes
    [15] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0145 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.185
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.32
    Notes
    [16] - 1-sided p-value

    Secondary: Percentage of subjects with mucosal healing at Week 12

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    End point title
    		 Percentage of subjects with mucosal healing at Week 12
    End point description
    Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central readerwere considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percentage of subjects
    number (confidence interval 90%)
        Centrally read (CR)
    8.2 (3.6 to 15.4)
    15.5 (9.5 to 23.6)
    27.8 (19.5 to 37.1)
    25.4 (17.1 to 35)
    14.3 (8 to 22.3)
        Locally read (LR)
    21.9 (14.9 to 31.4)
    22.5 (15.4 to 31.6)
    37.5 (28 to 47.2)
    35.2 (25.8 to 44.7)
    28.6 (20.2 to 38.2)
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0618 [17]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.081
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.162
    Notes
    [17] - 1-sided p-value
    Statistical analysis title
    		 PF-00547650 22.5 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0009 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.187
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.091
         upper limit
    		 0.284
    Notes
    [18] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0027 [19]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.159
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.068
         upper limit
    		 0.25
    Notes
    [19] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, CR
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0999 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.069
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.013
         upper limit
    		 0.151
    Notes
    [20] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5225 [21]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.001
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.111
         upper limit
    		 0.114
    Notes
    [21] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0246 [22]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.154
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.278
    Notes
    [22] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0464 [23]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.008
         upper limit
    		 0.253
    Notes
    [23] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, LR
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2 [24]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.066
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.053
         upper limit
    		 0.186
    Notes
    [24] - 1-sided p-value

    Secondary: Percentage of subjects with absolute Partial Mayo Score of less than or equal to (<=) 2 with no individual subscore more than (>) 1 at Weeks 4, 8, and 12

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    End point title
    		 Percentage of subjects with absolute Partial Mayo Score of less than or equal to (<=) 2 with no individual subscore more than (>) 1 at Weeks 4, 8, and 12
    End point description
    An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of "absolute Partial MayoScore <=2", it was stated as "change from baseline in Partial Mayo Score <=2". As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, and 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    0 [25]
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    Units: percentage of subjects
        number (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [25] - This endpoint was incorrectly stated in the protocol, no analyses were done.
    [26] - This endpoint was incorrectly stated in the protocol, no analyses were done.
    [27] - This endpoint was incorrectly stated in the protocol, no analyses were done.
    [28] - This endpoint was incorrectly stated in the protocol, no analyses were done.
    [29] - This endpoint was incorrectly stated in the protocol, no analyses were done.
    No statistical analyses for this end point

    Secondary: Change from baseline in Total Mayo Score at Week 12

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    End point title
    		 Change from baseline in Total Mayo Score at Week 12
    End point description
    The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. "n" signifies the number of evaluable subjects in that specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: units on a scale
    arithmetic mean (standard deviation)
        Centrally read (CR) baseline (n=73,71,72,71,70)
    8.4 ( 1.71 )
    8.7 ( 1.65 )
    8.1 ( 1.63 )
    8.4 ( 1.94 )
    8.7 ( 1.6 )
        Centrally read change (n=67,63,69,67,63)
    -1.5 ( 2.42 )
    -2.4 ( 2.78 )
    -2.9 ( 2.49 )
    -2.5 ( 2.74 )
    -2.9 ( 2.78 )
        Locally read (LR) baseline (n=73,70,72,70,70)
    8.4 ( 1.72 )
    8.8 ( 1.59 )
    8.1 ( 1.72 )
    8.3 ( 1.99 )
    8.6 ( 1.62 )
        Locally read change (n=67,62,70,66,64)
    -1.7 ( 2.55 )
    -2.7 ( 3.05 )
    -3.1 ( 2.7 )
    -2.7 ( 2.92 )
    -3.1 ( 3.07 )
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, CR change
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    P-value
    		 = 0.0494
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean (LSM) Difference
    Point estimate
    -0.88
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.623
         upper limit
    		 -0.145
    Notes
    [30] - Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, CR change
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -1.53
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.254
         upper limit
    		 -0.809
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, CR change
    Statistical analysis description
    ANCOVA with modelterms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0117
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -1.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.845
         upper limit
    		 -0.39
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, CR change
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0049
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -1.27
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.016
         upper limit
    		 -0.533
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, LR change
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0543
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -0.94
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.737
         upper limit
    		 -0.137
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, LR change
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.372
         upper limit
    		 -0.819
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, LR change
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0255
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -1.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.858
         upper limit
    		 -0.284
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, LR change
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0079
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -1.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.082
         upper limit
    		 -0.493

    Secondary: Percentage of subjects with change from baseline in individual Mayo subscores - stool frequency, rectal bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12

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    End point title
    		 Percentage of subjects with change from baseline in individual Mayo subscores - stool frequency, rectal bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12
    End point description
    The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency [freq], rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore. "n" signifies the number of evaluable subjects at that specific time point for that endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks (W) 4, 8, and 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percentage of subjects
    number (not applicable)
        Imp in Stool frequency, W4 (n=67,64,71,69,65)
    26.87
    46.88
    36.62
    30.43
    43.08
        NC in Stool frequency, W4 (n=67,64,71,69,65)
    59.7
    42.19
    60.56
    63.77
    52.31
        Wors in Stool frequency, W4 (n=67,64,71,69,65)
    13.43
    10.94
    2.82
    5.8
    4.62
        Imp in Stool frequency, W8 (n=71,63,71,69,68)
    28.17
    49.21
    43.66
    49.28
    51.47
        NC in Stool frequency, W8 (n=71,63,71,69,68)
    60.56
    42.86
    53.52
    46.38
    48.53
        Wors in Stool frequency, W8 (n=71,63,71,69,68)
    11.27
    7.94
    2.82
    4.35
    0
        Imp in Stool frequency, W12 (n=67,63,71,68,64)
    35.82
    49.21
    56.34
    45.59
    56.25
        NC in Stool frequency, W12 (n=67,63,71,68,64)
    52.24
    41.27
    38.03
    48.53
    37.5
        Wors in Stool frequency, W12 (n=67,63,71,68,64)
    11.94
    9.52
    5.63
    5.88
    6.25
        Imp in Rectal Bleeding, W4 (n=67,64,71,69,65)
    22.39
    48.44
    42.25
    42.03
    49.23
        NC in Rectal Bleeding, W4 (n=67,64,71,69,65)
    62.69
    42.19
    57.75
    53.62
    44.62
        Wors in Rectal Bleeding, W4 (n=67,64,71,69,65)
    14.93
    9.38
    0
    4.35
    6.15
        Imp in Rectal Bleeding, W8 (n=71,63,71,69,68)
    33.8
    50.79
    40.85
    46.38
    64.71
        NC in Rectal Bleeding, W8 (n=71,63,71,69,68)
    54.93
    36.51
    50.7
    44.93
    33.82
        Wors in Rectal Bleeding, W8 (n=71,63,71,69,68)
    11.27
    12.7
    8.45
    8.7
    1.47
        Imp in Rectal Bleeding, W12 (n=67,63,71,68,64)
    37.31
    53.97
    50.7
    47.06
    60.94
        NC in Rectal Bleeding, W12 (n=67,63,71,68,64)
    50.75
    34.92
    42.25
    45.59
    35.94
        Wors in Rectal Bleeding, W12 (n=67,63,71,68,64)
    11.94
    11.11
    7.04
    7.35
    3.13
        Imp in PGA, W4 (n=67,64,71,69,65)
    47.76
    57.81
    56.34
    56.52
    60
        NC in PGA, W4 (n=67,64,71,69,65)
    49.25
    34.38
    39.44
    42.03
    35.38
        Wors in PGA, W4 (n=67,64,71,69,65)
    2.99
    7.81
    4.23
    1.45
    4.62
        Imp in PGA, W8 (n=71,63,71,69,68)
    59.15
    61.9
    66.2
    62.32
    67.65
        NC in PGA, W8 (n=71,63,71,69,68)
    33.8
    30.16
    30.99
    37.68
    30.88
        Wors in PGA, W8 (n=71,63,71,69,68)
    7.04
    7.94
    2.82
    0
    1.47
        Imp in PGA, W12 (n=67,63,71,68,64)
    50.75
    61.9
    64.79
    55.88
    57.81
        NC in PGA, W12 (n=67,63,71,68,64)
    43.28
    31.75
    32.39
    39.71
    32.81
        Wors in PGA, W12 (n=67,63,71,68,64)
    5.97
    6.35
    2.82
    4.41
    9.38
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Stool Freq, W4
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 = 0.1016
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.511
         upper limit
    		 0.001
    Notes
    [31] - Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Stool Freq, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0654
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.529
         upper limit
    		 -0.03
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Stool Freq, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.15
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.472
         upper limit
    		 0.031
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Stool Freq, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0132
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.38
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.637
         upper limit
    		 -0.129
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Stool Freq, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0526
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.555
         upper limit
    		 -0.046
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Stool Freq, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0422
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.554
         upper limit
    		 -0.058
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Stool Frequency, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.011
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.39
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.637
         upper limit
    		 -0.137
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Stool Freq, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.755
         upper limit
    		 -0.254
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Stool Freq, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1611
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.475
         upper limit
    		 0.038
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Stool Freq, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0186
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.608
         upper limit
    		 -0.108
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Stool Freq, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1647
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.465
         upper limit
    		 0.039
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Stool Freq, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0231
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.607
         upper limit
    		 -0.097
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.46
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.658
         upper limit
    		 -0.26
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, Rectal Bleeding, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.52
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 -0.322
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, Rectal Bleeding, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.49
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.686
         upper limit
    		 -0.295
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, Rectal Bleeding, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0012
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.39
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.587
         upper limit
    		 -0.192
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, Rectal Bleeding, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0207
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.28
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.475
         upper limit
    		 -0.081
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, Rectal Bleeding, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0402
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.432
         upper limit
    		 -0.048
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, Rectal Bleeding, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0071
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.511
         upper limit
    		 -0.124
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, Rectal Bleeding, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.47
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.664
         upper limit
    		 -0.275
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, Rectal Bleeding, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0395
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.449
         upper limit
    		 -0.05
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, Rectal Bleeding, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0073
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.511
         upper limit
    		 -0.123
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, Rectal Bleeding, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0413
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.24
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.439
         upper limit
    		 -0.047
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, Rectal Bleeding, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0008
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.602
         upper limit
    		 -0.206
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, PGA, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1862
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.421
         upper limit
    		 0.046
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, PGA, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0998
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.455
         upper limit
    		 0
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, PGA, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1085
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.453
         upper limit
    		 0.006
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, PGA, W4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3161
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.372
         upper limit
    		 0.09
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, PGA, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4962
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.328
         upper limit
    		 0.136
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, PGA, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0371
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.512
         upper limit
    		 -0.06
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, PGA, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1212
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.441
         upper limit
    		 0.013
    Statistical analysis title
    		 PF-00547650 225 mg vs pbo, PGA, W8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.187
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.045
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, PGA, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1133
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.459
         upper limit
    		 0.009
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, PGA, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0022
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.43
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.653
         upper limit
    		 -0.198
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, PGA, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0788
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.475
         upper limit
    		 -0.016
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, PGA, W12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0717
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.485
         upper limit
    		 -0.022

    Secondary: Percentage of subjects with change from baseline in individual Mayo subscore - findings on flexible sigmoidoscopy - at Week 12

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    End point title
    		 Percentage of subjects with change from baseline in individual Mayo subscore - findings on flexible sigmoidoscopy - at Week 12
    End point description
    The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore. "n" signifies the number of evaluable subjects at Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percentage of subjects
    number (not applicable)
        Imp (n=67,63,69,67,63)
    25.37
    28.57
    47.83
    47.76
    39.68
        NC (n=67,63,69,67,63)
    61.19
    60.32
    49.28
    46.27
    57.14
        Wors (n=67,63,69,67,63)
    13.43
    11.11
    2.9
    5.97
    3.17
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5406
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -0.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.286
         upper limit
    		 0.131
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -0.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.628
         upper limit
    		 -0.221
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0063
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -0.34
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.549
         upper limit
    		 -0.137
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo
    Statistical analysis description
    ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0748
    Method
    		 ANCOVA
    Parameter type
    		 LSM Difference
    Point estimate
    -0.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.436
         upper limit
    		 -0.018

    Secondary: Percent change from baseline in fecal calprotectin at Weeks 4, 8, and 12

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    End point title
    		 Percent change from baseline in fecal calprotectin at Weeks 4, 8, and 12
    End point description
    Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study. "n" signifies the number of evaluable subjects at that specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 4, 8, and 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percent change
    geometric mean (confidence interval 90%)
        Week 4 (n=62,57,68,67,60)
    -25.62 (-43.49 to -2.09)
    -40.21 (-55.56 to -19.54)
    -23.5 (-44.27 to 5)
    -46.22 (-61.46 to -24.95)
    -39.27 (-56.74 to -14.75)
        Week 8 (n=67,57,67,63,65)
    -21.68 (-39.62 to 1.6)
    -44.49 (-60.05 to -22.88)
    -44.77 (-60.49 to -22.8)
    -57.2 (-69.74 to -39.45)
    -49.54 (-65.08 to -27.07)
        Week 12 (n=61,55,64,64,59)
    -22.59 (-42.68 to 4.54)
    -56.34 (-69.39 to -37.72)
    -58.41 (-72.26 to -37.65)
    -56.72 (-71.67 to -33.88)
    -64.52 (-76.92 to -45.43)
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9744
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -101
         upper limit
    		 97.14
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2023
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    74.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -21.77
         upper limit
    		 171.66
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5808
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    32.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -65.09
         upper limit
    		 130.79
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5388
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    37.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -63.12
         upper limit
    		 138.34
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8902
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -8.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -106.24
         upper limit
    		 89.81
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8616
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Differennce
    Point estimate
    10.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -86.14
         upper limit
    		 106.54
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5684
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -34.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -133.49
         upper limit
    		 64.79
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.57
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    33.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -64.2
         upper limit
    		 131.86
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6234
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -30
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -130.56
         upper limit
    		 70.57
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5474
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -62.44
         upper limit
    		 134.38
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1918
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    78.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -20.48
         upper limit
    		 177.56
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9615
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -104.88
         upper limit
    		 98.91

    Secondary: Percent change from baseline in high sensitivity C-reactive protein (hsCRP) at Weeks 4, 8, and 12

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    End point title
    		 Percent change from baseline in high sensitivity C-reactive protein (hsCRP) at Weeks 4, 8, and 12
    End point description
    hsCRP was one of the PD biomarkers of the study. "n" signifies the number of evaluable subjects at that specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 4, 8, and 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: percent change
    geometric mean (confidence interval 90%)
        Week 4 (n=67,64,69,71,65)
    -11.6 (-25.69 to 5.17)
    -19.17 (-34.22 to -0.67)
    -26.9 (-39.41 to -11.82)
    -35.21 (-49.1 to -17.55)
    -17.7 (-30.08 to -3.13)
        Week 8 (n=71,63,69,71,68)
    -2.42 (-22.75 to 23.25)
    -6 (-23.09 to 14.89)
    -31.43 (-44.11 to -15.88)
    -43.15 (-54.57 to -28.86)
    -22.7 (-36.72 to -5.59)
        Week 12 (n=67,62,68,71,64)
    14.85 (-11.16 to 48.48)
    4.51 (-18.02 to 33.25)
    -20.4 (-38.61 to 3.22)
    -15.96 (-33.12 to 5.6)
    2.31 (-18.48 to 28.42)
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9328
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    6.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -118.6
         upper limit
    		 131.41
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8962
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -9.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -132.91
         upper limit
    		 113.39
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8775
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    11.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -110.83
         upper limit
    		 133.74
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Week 4
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8224
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -17
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -142.02
         upper limit
    		 107.94
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4831
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -52.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -176.48
         upper limit
    		 71.02
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1183
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -115.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -236.63
         upper limit
    		 6.13
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1139
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -115.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -236.29
         upper limit
    		 4.69
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Week 8
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1931
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -96.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -218.17
         upper limit
    		 25.46
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1182
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -119.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -245.66
         upper limit
    		 6.32
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5784
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -41.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -165.34
         upper limit
    		 81.87
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0279
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -163.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -285.84
         upper limit
    		 -41.29
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo, Week 12
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1053
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -123.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -249
         upper limit
    		 1.93

    Secondary: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12

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    End point title
    		 Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12
    End point description
    IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in subjects with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. "n" signifies the number of evaluable subjects at the specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (BL) (n=69,68,65,71,66)
    128 ( 30.69 )
    122.1 ( 38.82 )
    133.4 ( 34.79 )
    128 ( 32.42 )
    132.3 ( 36.84 )
        Change at W12 (n=62,55,61,64,54)
    19.8 ( 34.08 )
    20.1 ( 35.24 )
    32.7 ( 34.1 )
    32.1 ( 31.7 )
    36.2 ( 29.45 )
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, W12 change from BL
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8302
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -9.507
         upper limit
    		 7.317
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, W12 change from BL
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0141
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    12.33
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 4.084
         upper limit
    		 20.567
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, W12 change from BL
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0182
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    11.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.564
         upper limit
    		 19.84
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, W12 change from BL
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0026
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    15.48
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 7.056
         upper limit
    		 23.907

    Secondary: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 12

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    End point title
    		 Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 12
    End point description
    IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in subjects with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional (emot) status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain. "n" signifies the number of evaluable subjects at the specified time point for that specific domain.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72
    71
    70
    Units: units on a scale
    arithmetic mean (standard deviation)
        BL, bowel fx (n=69,68,65,71,66)
    38.9 ( 9.96 )
    37 ( 12.23 )
    41.7 ( 10.6 )
    38.5 ( 9.95 )
    41 ( 11.37 )
        Change at W12, bowel fx (n=62,55,61,64,54)
    7.4 ( 11.93 )
    6.9 ( 12.51 )
    11.3 ( 11.05 )
    11.8 ( 12.07 )
    12.8 ( 11.45 )
        BL, emotional fx (n=69,68,65,71,66)
    50.4 ( 12.6 )
    48.4 ( 15.39 )
    51.2 ( 14.7 )
    50.4 ( 13.73 )
    51.3 ( 15.92 )
        Change at W12, emotional fx (n=62,55,61,64,54)
    5.9 ( 11.91 )
    6.6 ( 12.22 )
    10.8 ( 13.85 )
    10 ( 12.04 )
    12 ( 11.4 )
        BL, systemic symptoms (SS) (n=69,68,65,71,66)
    18.1 ( 5.62 )
    18.2 ( 6.81 )
    19.6 ( 5.98 )
    18.4 ( 6.42 )
    19 ( 5.97 )
        Change at W12, SS (n=62,55,61,64,54)
    3.3 ( 6.67 )
    3.1 ( 5.95 )
    4.7 ( 5.91 )
    4.9 ( 5.49 )
    4.8 ( 5.05 )
        BL, social fx (n=69,68,65,71,66)
    20.6 ( 7.87 )
    18.5 ( 8.07 )
    20.9 ( 7.37 )
    20.7 ( 6.99 )
    20.9 ( 7.73 )
        Change at W12, social fx (n=62,55,61,64,54)
    3.3 ( 6.27 )
    3.6 ( 7.33 )
    5.9 ( 6.51 )
    5.4 ( 6.9 )
    6.6 ( 6.58 )
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, bowel fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6862
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.73
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.689
         upper limit
    		 2.235
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, bowel fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0135
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    4.37
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.467
         upper limit
    		 7.28
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, bowel fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0171
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    4.16
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.293
         upper limit
    		 7.023
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, bowel fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0041
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    5.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.232
         upper limit
    		 8.172
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, emot fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9072
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.897
         upper limit
    		 3.339
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, emot fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0161
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    4.47
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.42
         upper limit
    		 7.522
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, emot fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0271
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    4.06
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.042
         upper limit
    		 7.071
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, emot fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    5.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.778
         upper limit
    		 9.026
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, SS, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7711
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.26
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.756
         upper limit
    		 1.229
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, SS, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0582
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    1.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.223
         upper limit
    		 3.147
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, SS, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0558
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    1.68
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.235
         upper limit
    		 3.12
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, SS, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0686
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    1.66
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.161
         upper limit
    		 3.153
    Statistical analysis title
    		 PF-00547659 7.5 mg vs pbo, social fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7561
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    -0.33
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.094
         upper limit
    		 1.429
    Statistical analysis title
    		 PF-00547659 22.5 mg vs pbo, social fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0384
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    2.17
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.447
         upper limit
    		 3.891
    Statistical analysis title
    		 PF-00547659 75 mg vs pbo, social fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0729
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    1.86
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.154
         upper limit
    		 3.557
    Statistical analysis title
    		 PF-00547659 225 mg vs pbo, social fx, W12 change
    Statistical analysis description
    LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM Difference
    Point estimate
    2.95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 4.715

    Secondary: Percentage of subjects with an Inflammatory Bowel Disease Questionnaire (IBDQ) total score of more than or equal to (>=) 170 at Week 12

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    End point title
    		 Percentage of subjects with an Inflammatory Bowel Disease Questionnaire (IBDQ) total score of more than or equal to (>=) 170 at Week 12
    End point description
    IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in subjects with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    65
    57
    63
    64
    54
    Units: percentage of subjects
        number (confidence interval 90%)
    36.9 (27.4 to 47.5)
    36.8 (26.9 to 47.9)
    55.6 (45 to 66.3)
    46.9 (36.1 to 57.5)
    48.1 (36.3 to 59.4)
    Statistical analysis title
    		 PF-00547659 7.5 mg vs placebo
    Comparison groups
    Placebo v PF-00547659 7.5 mg
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5201 [32]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.002
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.145
         upper limit
    		 0.142
    Notes
    [32] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 22.5 mg vs placebo
    Comparison groups
    Placebo v PF-00547659 22.5 mg
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0217 [33]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.183
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.039
         upper limit
    		 0.328
    Notes
    [33] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 75 mg vs placebo
    Comparison groups
    Placebo v PF-00547659 75 mg
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1473 [34]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.096
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.045
         upper limit
    		 0.237
    Notes
    [34] - 1-sided p-value
    Statistical analysis title
    		 PF-00547659 225 mg vs placebo
    Comparison groups
    Placebo v PF-00547659 225 mg
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1231 [35]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.112
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.038
         upper limit
    		 0.261
    Notes
    [35] - 1-sided p-value

    Secondary: Number of subjects with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and withdrawals due to TEAEs during the treatment period (Weeks 0-12)

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    End point title
    		 Number of subjects with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and withdrawals due to TEAEs during the treatment period (Weeks 0-12)
    End point description
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a subject who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs.An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Secondary
    End point timeframe
    Screening through to end of treatment period, up to 12 weeks
    End point values
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    73
    71
    72 [36]
    71 [37]
    70
    Units: subjects
    number (not applicable)
        With TEAEs
    39
    41
    36
    43
    43
        With SAEs
    4
    11
    1
    3
    3
        Withdrawals due to TEAEs
    2
    6
    0
    3
    1
    Notes
    [36] - 2 subjects in this group were counted under 75 mg group for safety as they received 75 mg instead.
    [37] - 2 subjects in the 22.5 mg group were counted under the 75 mg group for safety。
    No statistical analyses for this end point

    Secondary: Maximum serum PF-00547659 concentration achieved

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    End point title
    		 Maximum serum PF-00547659 concentration achieved [38]
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 0 (baseline), 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: According to the protocol, all samples from placebo-treated subjects may not have been analyzed.
    End point values
    		 PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Number of subjects analysed
    67
    67
    68
    62
    Units: nanograms (ng)/milliliter (mL)
        arithmetic mean (standard deviation)
    929.4 ( 1977.8 )
    2062 ( 1395.5 )
    6576 ( 2146 )
    21470 ( 4788.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening till Week 36 or Early Withdrawal, whichever was later.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 7.5 mg
    Reporting group description
    		 Subjects received PF-00547659 7.5 milligrams(mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 22.5 mg
    Reporting group description
    		 Subjects received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 75 mg
    Reporting group description
    		 Subjects received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Reporting group title
    PF-00547659 225 mg
    Reporting group description
    		 Subjects received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Subjects were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.

    Serious adverse events
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 73 (5.48%)
    11 / 71 (15.49%)
    2 / 70 (2.86%)
    4 / 73 (5.48%)
    3 / 70 (4.29%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Colectomy total
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Migraine
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 73 (1.37%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Eye disorders
    Retinal artery embolism
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Anal fistula
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 73 (1.37%)
    6 / 71 (8.45%)
    0 / 70 (0.00%)
    2 / 73 (2.74%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 6
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Diarrhoea
         subjects affected / exposed
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 73 (1.37%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Vomiting
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Appendicitis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Clostridium difficile infection
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 73 (1.37%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 73 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo PF-00547659 7.5 mg PF-00547659 22.5 mg PF-00547659 75 mg PF-00547659 225 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 73 (23.29%)
    16 / 71 (22.54%)
    15 / 70 (21.43%)
    14 / 73 (19.18%)
    18 / 70 (25.71%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 73 (8.22%)
    5 / 71 (7.04%)
    7 / 70 (10.00%)
    4 / 73 (5.48%)
    8 / 70 (11.43%)
         occurrences all number
    8
    5
    15
    4
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    2 / 70 (2.86%)
    4 / 73 (5.48%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    2
    4
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 73 (2.74%)
    6 / 71 (8.45%)
    3 / 70 (4.29%)
    2 / 73 (2.74%)
    1 / 70 (1.43%)
         occurrences all number
    3
    6
    3
    3
    1
    Nausea
         subjects affected / exposed
    3 / 73 (4.11%)
    6 / 71 (8.45%)
    1 / 70 (1.43%)
    1 / 73 (1.37%)
    4 / 70 (5.71%)
         occurrences all number
    3
    7
    1
    1
    4
    Vomiting
         subjects affected / exposed
    3 / 73 (4.11%)
    1 / 71 (1.41%)
    4 / 70 (5.71%)
    0 / 73 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    4
    1
    4
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 73 (5.48%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    1 / 73 (1.37%)
    0 / 70 (0.00%)
         occurrences all number
    4
    1
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 73 (4.11%)
    0 / 71 (0.00%)
    3 / 70 (4.29%)
    5 / 73 (6.85%)
    4 / 70 (5.71%)
         occurrences all number
    3
    0
    4
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2013
    Updated exclusion criterion to exclude subjects with diagnosis of ischaemic colitis, radiation colitis, diverticular disease associated with colitis, and microscopic colitis
    18 Mar 2013
    Corrected duration of subject participation from approximately 38 months to 28 months; Updated exclusion criteria; Clarified that unblinded preparer may also administer investigational drug to subject(s) and that no unblinded personnel may participate in evaluation of subject(s); Blood volume section revision; Revision to allow other qualified physicians to read radiograph; References to procedures for additional pharmacokinetic sampling for only Japanese subjects in Japan removed due to Japan not participating in this study; Other updates to align with current protocol template including section on Data Monitoring Committee

    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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