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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-Blind, Placebo Controlled Study of PF-06700841 to Evaluate the Efficacy at 16 Weeks and to Evaluate the Safety and Efficacy up to 1 Year in Subjects with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2018-004241-16
    Trial protocol
    		 SK   HU   CZ   BG   LT   EE   ES  
    Global end of trial date
    15 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jul 2021
    First version publication date
    09 Jul 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B7931030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03963401
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc, +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc, +1 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
    02 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate at Week 16 the efficacy of PF-06700841 in subjects with active Psoriatic Arthritis (PsA). The 36 weeks (Week 17 - Week 52) built in extension period was to provide an opportunity for all subjects to receive additional active study treatment up to 1 year.
    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 Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2019
    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: 7
    Country: Number of subjects enrolled
    Bulgaria: 27
    Country: Number of subjects enrolled
    Czechia: 37
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Lithuania: 7
    Country: Number of subjects enrolled
    Poland: 80
    Country: Number of subjects enrolled
    Russian Federation: 37
    Country: Number of subjects enrolled
    Serbia: 4
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Spain: 5
    Worldwide total number of subjects
    218
    EEA total number of subjects
    170
    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)
    202
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study consisted of a screening period of up to 5 weeks, a double blind treatment period of 52 weeks, including a placebo controlled phase from Day 1 to Week 16 visits and an extended active treatment phase from Week 17 through Week 52.

    Pre-assignment
    Screening details
    		 A total of 219 subjects were enrolled in this study and 1 of them didn't receive any study treatment.

    Period 1
    Period 1 title
    Initial Period (Day1-Week 16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) from Day 1 to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 60 mg QD from Day 1 to Week 16.

    Arm title
    		 PF-06700841 30 mg QD -> PF-06700841 30 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 30 mg QD from Day 1 to Week 16.

    Arm title
    		 PF-06700841 10 mg QD -> PF-06700841 60 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 10 mg QD from Day 1 to Week 16.

    Arm title
    		 PF-06700841 10 mg QD -> PF-06700841 30 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 10 mg QD from Day 1 to Week 16.

    Arm title
    		 Placebo -> PF-06700841 60 mg QD
    Arm description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Placebo QD from Day 1 to Week 16.

    Arm title
    		 Placebo -> PF-06700841 30 mg QD
    Arm description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching PF-06700841
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Placebo QD from Day 1 to Week 16.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is a double-blind study where neither the subjects nor the experimenters know the particular treatment. Subjects, Care Provider, Outcome Assessor, where Carer and Assessor belongs to experimenters in above double blind criteria.
    Number of subjects in period 1
    		PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Started
    60
    60
    16
    15
    34
    33
    Completed
    57
    57
    14
    13
    31
    31
    Not completed
    3
    3
    2
    2
    3
    2
         Consent withdrawn by subject
    2
    1
    1
    1
    2
    -
         Adverse event, non-fatal
    1
    2
    -
    -
    1
    2
         Lack of efficacy
    -
    -
    1
    1
    -
    -
    Period 2
    Period 2 title
    Extension Period (Week 17- Week 52)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [2]
    Roles blinded
    		 Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 60 mg QD from Week 17 to Week 52.

    Arm title
    		 PF-06700841 30 mg QD -> PF-06700841 30 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 30 mg QD from Week 17 to Week 52.

    Arm title
    		 PF-06700841 10 mg QD -> PF-06700841 60 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 60 mg QD from Week 17 to Week 52.

    Arm title
    		 PF-06700841 10 mg QD -> PF-06700841 30 mg QD
    Arm description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 30 mg QD from Week 17 to Week 52.

    Arm title
    		 Placebo -> PF-06700841 60 mg QD
    Arm description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 60 mg QD from Week 17 to Week 52.

    Arm title
    		 Placebo -> PF-06700841 30 mg QD
    Arm description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06700841
    Investigational medicinal product code
    Other name
    Brepocitinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received PF-06700841 30 mg QD from Week 17 to Week 52.

    Notes
    [2] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is a double-blind study where neither the subjects nor the experimenters know the particular treatment. Subjects, Care Provider, Outcome Assessor, where Carer and Assessor belongs to experimenters in above double blind criteria.
    Number of subjects in period 2
    		PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Started
    57
    57
    14
    13
    31
    31
    Completed
    43
    52
    10
    12
    25
    26
    Not completed
    14
    5
    4
    1
    6
    5
         Consent withdrawn by subject
    4
    1
    -
    -
    1
    1
         Adverse event, non-fatal
    6
    3
    2
    -
    4
    3
         Non-Compliance With Study Drug
    1
    -
    -
    -
    -
    -
         Unspecified
    1
    1
    -
    1
    1
    1
         No Longer Meets Eligibility Criteria
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    -
         Lack of efficacy
    1
    -
    1
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    PF-06700841 60 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) from Day 1 to Week 52.

    Reporting group title
    PF-06700841 30 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 52.

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.

    Reporting group title
    Placebo -> PF-06700841 60 mg QD
    Reporting group description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.

    Reporting group title
    Placebo -> PF-06700841 30 mg QD
    Reporting group description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.

    Reporting group values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD Total
    Number of subjects
    		 60 60 16 15 34 33 218
    Age Categorical
    Units: Subjects
        18-44 Years
    		 22 26 9 6 13 14 90
        45-64 Years
    		 35 31 5 8 17 16 112
        >=65 Years
    		 3 3 2 1 4 3 16
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48.68 ( 11.47 ) 45.85 ( 10.23 ) 47.81 ( 14.16 ) 47.73 ( 12.95 ) 47.94 ( 12.58 ) 48.48 ( 11.84 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 34 32 7 7 20 16 116
        Male
    		 26 28 9 8 14 17 102
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 59 60 16 15 34 33 217
        Black or African American
    		 0 0 0 0 0 0 0
        Asian
    		 1 0 0 0 0 0 1
        Other
    		 0 0 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 60 59 16 15 33 32 215
        Not reported
    		 0 1 0 0 1 1 3
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received Placebo matched to PF-06700841 through the initial 16-week treatment period.

    Subject analysis set title
    PF 06700841 10 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received PF-06700841 tablet orally at 10 mg QD through the initial 16-week treatment period.

    Subject analysis set title
    PF 06700841 30 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received PF-06700841 tablet orally at 30 mg QD through the initial 16-week treatment period.

    Subject analysis set title
    PF 06700841 60 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received PF-06700841 tablet orally at 60 mg QD through the initial 16-week treatment period.

    Subject analysis sets values
    		 Placebo PF 06700841 10 mg QD PF 06700841 30 mg QD PF 06700841 60 mg QD
    Number of subjects
    67
    31
    60
    60
    Age Categorical
    Units: Subjects
        18-44 Years
    27
    15
    26
    22
        45-64 Years
    33
    13
    31
    35
        >=65 Years
    7
    3
    3
    3
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Subjects
        Female
    36
    14
    32
    34
        Male
    31
    17
    28
    26
    Race/Ethnicity, Customized
    Units: Subjects
        White
    67
    31
    60
    59
        Black or African American
    0
    0
    0
    0
        Asian
    0
    0
    0
    1
        Other
    0
    0
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    65
    31
    59
    60
        Not reported
    2
    0
    1
    0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    PF-06700841 60 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 60 milligram (mg) once daily (QD) from Day 1 to Week 52.

    Reporting group title
    PF-06700841 30 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 52.

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.

    Reporting group title
    Placebo -> PF-06700841 60 mg QD
    Reporting group description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.

    Reporting group title
    Placebo -> PF-06700841 30 mg QD
    Reporting group description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.
    Reporting group title
    PF-06700841 60 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 52.

    Reporting group title
    PF-06700841 30 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 52.

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.

    Reporting group title
    Placebo -> PF-06700841 60 mg QD
    Reporting group description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 60 mg QD.

    Reporting group title
    Placebo -> PF-06700841 30 mg QD
    Reporting group description
    		 Placebo matched to PF-06700841 was administered orally QD from Day 1 to Week 16. From Week 17 to Week 52, PF-06700841 tablet was administered orally at 30 mg QD.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received Placebo matched to PF-06700841 through the initial 16-week treatment period.

    Subject analysis set title
    PF 06700841 10 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received PF-06700841 tablet orally at 10 mg QD through the initial 16-week treatment period.

    Subject analysis set title
    PF 06700841 30 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received PF-06700841 tablet orally at 30 mg QD through the initial 16-week treatment period.

    Subject analysis set title
    PF 06700841 60 mg QD
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received PF-06700841 tablet orally at 60 mg QD through the initial 16-week treatment period.

    Primary: Percentage of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
    End point description
    The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR’s definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a >=20% improvement in tender and swollen joint counts and >=20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute phase reactant. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment and had ACR response.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo PF 06700841 10 mg QD PF 06700841 30 mg QD PF 06700841 60 mg QD
    Number of subjects analysed
    67
    31
    60
    59
    Units: Percentage of subjects
        number (confidence interval 95%)
    43.28 (31.42 to 55.15)
    64.52 (47.67 to 81.36)
    66.67 (54.74 to 78.59)
    74.58 (63.47 to 85.69)
    Statistical analysis title
    		 Placebo, PF-06700841 10 mg QD
    Comparison groups
    PF 06700841 10 mg QD v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1172
    Method
    		 Normal Approximation,Dunnett's Method
    Parameter type
    		 Percentage difference
    Point estimate
    21.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.94
         upper limit
    		 38.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.51
    Statistical analysis title
    		 Placebo, PF-06700841 30 mg QD
    Comparison groups
    Placebo v PF 06700841 30 mg QD
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0197
    Method
    		 Normal Approximation,Dunnett's Method
    Parameter type
    		 Percentage difference
    Point estimate
    23.38
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 9.26
         upper limit
    		 37.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.58
    Statistical analysis title
    		 Placebo, PF-06700841 60 mg QD
    Comparison groups
    Placebo v PF 06700841 60 mg QD
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Normal Approximation,Dunnett's Method
    Parameter type
    		 Percentage difference
    Point estimate
    31.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 17.65
         upper limit
    		 44.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.29

    Secondary: Percentage of Tumor Necrosis Factor (TNF) Inhibitor-Naïve Subjects Achieving an ACR20 response at Week 16

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    End point title
    		 Percentage of Tumor Necrosis Factor (TNF) Inhibitor-Naïve Subjects Achieving an ACR20 response at Week 16
    End point description
    The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR’s definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a >=20% improvement in tender and swollen joint counts and >=20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute phase reactant. Number of Subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment with prior TNFi naive and had ACR response.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo PF 06700841 10 mg QD PF 06700841 30 mg QD PF 06700841 60 mg QD
    Number of subjects analysed
    60
    28
    56
    55
    Units: Percentage of subjects
        number (confidence interval 95%)
    43.33 (30.79 to 55.87)
    64.29 (46.54 to 82.03)
    69.64 (57.60 to 81.69)
    74.55 (63.03 to 86.06)
    Statistical analysis title
    		 Placebo, PF-06700841 10 mg QD
    Comparison groups
    Placebo v PF 06700841 10 mg QD
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0588
    Method
    		 normal approximation
    Parameter type
    		 Percentage difference
    Point estimate
    20.95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 2.72
         upper limit
    		 39.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.09
    Statistical analysis title
    		 Placebo, PF-06700841 30 mg QD
    Comparison groups
    Placebo v PF 06700841 30 mg QD
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 normal approximation
    Parameter type
    		 Percentage difference
    Point estimate
    26.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 11.72
         upper limit
    		 40.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.87
    Statistical analysis title
    		 Placebo, PF 06700841 60 mg QD
    Comparison groups
    Placebo v PF 06700841 60 mg QD
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 normal approximation
    Parameter type
    		 Percentage difference
    Point estimate
    31.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 16.93
         upper limit
    		 45.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.68

    Secondary: Percentage of Subjects Achieving an ACR20 Response at All Treatment Timepoints (except Week 16): Week 2, 4, 8, 12, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving an ACR20 Response at All Treatment Timepoints (except Week 16): Week 2, 4, 8, 12, 20, 28, 36, 44, and 52
    End point description
    The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR’s definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a >=20% improvement in tender and swollen joint counts and >=20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute phase reactant. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment and had ACR response.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, 12, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 2
    21.67 (11.24 to 32.09)
    18.33 (8.54 to 28.12)
    18.75 (0.00 to 37.87)
    3.13 (0.00 to 11.65)
    5.88 (0.00 to 13.79)
    18.18 (5.02 to 31.34)
        Week 4
    45.00 (32.41 to 57.59)
    51.67 (39.02 to 64.31)
    31.25 (8.54 to 53.96)
    20.00 (0.00 to 40.24)
    14.71 (2.80 to 26.61)
    24.24 (9.62 to 38.86)
        Week 8
    66.67 (54.74 to 78.59)
    55.00 (42.41 to 67.59)
    50.00 (25.50 to 74.50)
    40.00 (15.21 to 64.79)
    35.29 (19.23 to 51.36)
    42.42 (25.56 to 59.29)
        Week 12
    70.00 (58.40 to 81.60)
    63.33 (51.14 to 75.53)
    56.25 (31.94 to 80.56)
    60.00 (35.21 to 84.79)
    44.12 (27.43 to 60.81)
    39.39 (22.72 to 56.07)
        Week 20
    81.67 (71.88 to 91.46)
    80.00 (69.88 to 90.12)
    68.75 (46.04 to 91.46)
    60.00 (35.21 to 84.79)
    73.53 (58.70 to 88.36)
    75.76 (61.14 to 90.38)
        Week 28
    73.33 (62.14 to 84.52)
    78.33 (67.91 to 88.76)
    68.75 (46.04 to 91.46)
    73.33 (50.95 to 95.71)
    64.71 (48.64 to 80.77)
    81.82 (68.66 to 94.98)
        Week 36
    66.67 (54.74 to 78.59)
    78.33 (67.91 to 88.76)
    68.75 (46.04 to 91.46)
    80.00 (59.76 to 100.00)
    64.71 (48.64 to 80.77)
    81.82 (68.66 to 94.98)
        Week 44
    68.33 (56.56 to 80.10)
    73.33 (62.14 to 84.52)
    62.50 (38.78 to 86.22)
    73.33 (50.95 to 95.71)
    67.65 (51.92 to 83.37)
    75.76 (61.14 to 90.38)
        Week 52
    61.67 (49.36 to 73.97)
    70.00 (58.40 to 81.60)
    56.25 (31.94 to 80.56)
    60.00 (35.21 to 84.79)
    61.76 (45.43 to 78.10)
    66.67 (50.58 to 82.75)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving an ACR50 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving an ACR50 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR’s definition for calculating improvement in rheumatoid arthritis (ACR50) is calculated as a >=50% improvement in tender and swollen joint counts and >=50% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute phase reactant. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment and had ACR response.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 2
    6.67 (0.35 to 12.98)
    1.67 (0.00 to 4.91)
    2.94 (0.00 to 10.97)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 4
    13.33 (4.73 to 21.93)
    16.67 (7.24 to 26.10)
    2.94 (0.00 to 10.97)
    6.67 (0.00 to 19.29)
    2.94 (0.00 to 8.62)
    6.06 (0.00 to 14.20)
        Week 8
    31.67 (19.90 to 43.44)
    25.00 (14.04 to 35.96)
    18.75 (0.00 to 37.87)
    13.33 (0.00 to 30.54)
    11.76 (0.93 to 22.59)
    15.15 (2.92 to 27.38)
        Week 12
    43.33 (30.79 to 55.87)
    31.67 (19.90 to 43.44)
    31.25 (8.54 to 53.96)
    20.00 (0.00 to 40.24)
    23.53 (9.27 to 37.79)
    12.12 (0.99 to 23.26)
        Week 16
    44.07 (31.40 to 56.74)
    48.33 (35.69 to 60.98)
    31.25 (8.54 to 53.96)
    33.33 (9.48 to 57.19)
    14.71 (2.80 to 26.61)
    6.06 (0.00 to 14.20)
        Week 20
    61.67 (49.36 to 73.97)
    53.33 (40.71 to 65.96)
    37.50 (13.78 to 61.22)
    40.00 (15.21 to 64.79)
    44.12 (27.43 to 60.81)
    45.45 (28.47 to 62.44)
        Week 28
    56.67 (44.13 to 69.21)
    51.67 (39.02 to 64.31)
    43.75 (19.44 to 68.06)
    53.33 (28.09 to 78.58)
    41.18 (24.63 to 57.72)
    66.67 (50.58 to 82.75)
        Week 36
    53.33 (40.71 to 65.96)
    56.67 (44.13 to 69.21)
    50.00 (25.50 to 74.50)
    66.67 (42.81 to 90.52)
    50.00 (33.19 to 66.81)
    57.58 (40.71 to 74.44)
        Week 44
    56.67 (44.13 to 69.21)
    55.00 (42.41 to 67.59)
    43.75 (19.44 to 68.06)
    60.00 (35.21 to 84.79)
    58.82 (42.28 to 75.37)
    63.64 (47.22 to 80.05)
        Week 52
    46.67 (34.04 to 59.29)
    58.33 (45.86 to 70.81)
    43.75 (19.44 to 68.06)
    46.67 (21.42 to 71.91)
    41.18 (24.63 to 57.72)
    51.52 (34.46 to 68.57)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving an ACR70 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving an ACR70 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR’s definition for calculating improvement in rheumatoid arthritis (ACR70) is calculated as a >=70% improvement in tender and swollen joint counts and >=70% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute phase reactant. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment and had ACR response.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 2
    3.33 (0.00 to 7.88)
    1.67 (0.00 to 4.91)
    2.94 (0.00 to 10.97)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 4
    5.00 (0.00 to 10.51)
    5.00 (0.00 to 10.51)
    2.94 (0.00 to 10.97)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 8
    11.67 (3.54 to 19.79)
    11.67 (3.54 to 19.79)
    6.25 (0.00 to 18.11)
    3.13 (0.00 to 11.65)
    2.94 (0.00 to 8.62)
    3.03 (0.00 to 8.88)
        Week 12
    21.67 (11.24 to 32.09)
    18.33 (8.54 to 28.12)
    6.25 (0.00 to 18.11)
    6.67 (0.00 to 19.29)
    1.43 (0.00 to 5.36)
    9.09 (0.00 to 18.90)
        Week 16
    23.73 (12.87 to 34.58)
    26.67 (15.48 to 37.86)
    6.25 (0.00 to 18.11)
    13.33 (0.00 to 30.54)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 20
    35.00 (22.93 to 47.07)
    30.00 (18.40 to 41.60)
    12.50 (0.00 to 28.70)
    20.00 (0.00 to 40.24)
    23.53 (9.27 to 37.79)
    27.27 (12.08 to 42.47)
        Week 28
    36.67 (24.47 to 48.86)
    38.33 (26.03 to 50.64)
    18.75 (0.00 to 37.87)
    26.67 (4.29 to 49.05)
    23.53 (9.27 to 37.79)
    42.42 (25.56 to 59.29)
        Week 36
    40.00 (27.60 to 52.40)
    35.00 (22.93 to 47.07)
    37.50 (13.78 to 61.22)
    26.67 (4.29 to 49.05)
    35.29 (19.23 to 51.36)
    39.39 (22.72 to 56.07)
        Week 44
    46.67 (34.04 to 59.29)
    45.00 (32.41 to 57.59)
    37.50 (13.78 to 61.22)
    40.00 (15.21 to 64.79)
    23.53 (9.27 to 37.79)
    51.52 (34.46 to 68.57)
        Week 52
    38.33 (26.03 to 50.64)
    45.00 (32.41 to 57.59)
    31.25 (8.54 to 53.96)
    26.67 (4.29 to 49.05)
    35.29 (19.23 to 51.36)
    42.42 (25.56 to 59.29)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender/painful Joint Count at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Tender/painful Joint Count at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    Tender/painful joint count is to count the tender/painful joint based on 68 joints. The 68 joints to be assessed for tenderness are: Upper Body: 2 temporomandibular, 2 sternoclavicular, 2 acromioclavicular; Upper Extremity: 2 shoulder, 2 elbow, 2 wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), 10 metacarpophalangeals, 2 thumb interphalangeal (IP), 8 proximal interphalangeals, 8 distal interphalangeals; Lower Extremity: 2 hip, 2 knee, 2 ankle, 2 tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), 10 metatarsophalangeals (MTP I, II, III, IV, V), 2 great toe interphalangeal (IP), 8 proximal and distal interphalangeal combined (PIP II, III, IV, V). The baseline is defined as the measurements in Day 1. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -3.3 ( 5.23 )
    -2.7 ( 4.49 )
    -4.7 ( 6.37 )
    0.0 ( 2.70 )
    -1.9 ( 3.27 )
    -2.1 ( 5.41 )
        Week 4
    -6.3 ( 7.96 )
    -5.1 ( 5.43 )
    -5.6 ( 8.93 )
    -2.8 ( 4.49 )
    -3.4 ( 5.47 )
    -4.3 ( 8.25 )
        Week 8
    -9.4 ( 7.69 )
    -6.8 ( 6.49 )
    -7.9 ( 7.89 )
    -4.4 ( 6.42 )
    -5.0 ( 6.46 )
    -4.6 ( 8.41 )
        Week 12
    -9.8 ( 8.19 )
    -8.7 ( 7.27 )
    -11.3 ( 7.32 )
    -6.2 ( 8.43 )
    -6.5 ( 6.69 )
    -6.4 ( 9.40 )
        Week 16
    -11.1 ( 8.01 )
    -10.1 ( 7.33 )
    -12.0 ( 8.80 )
    -10.4 ( 8.69 )
    -6.5 ( 5.78 )
    -6.5 ( 7.81 )
        Week 20
    -12.2 ( 8.20 )
    -10.2 ( 6.60 )
    -13.6 ( 9.65 )
    -11.2 ( 10.95 )
    -8.8 ( 5.94 )
    -10.2 ( 7.41 )
        Week 28
    -12.6 ( 8.38 )
    -10.4 ( 7.04 )
    -14.9 ( 9.99 )
    -13.5 ( 12.21 )
    -9.6 ( 6.39 )
    -11.4 ( 8.13 )
        Week 36
    -12.5 ( 8.66 )
    -10.7 ( 7.00 )
    -16.2 ( 9.45 )
    -13.8 ( 11.89 )
    -10.4 ( 6.12 )
    -11.4 ( 8.82 )
        Week 44
    -13.6 ( 8.54 )
    -11.6 ( 7.91 )
    -17.9 ( 10.07 )
    -12.6 ( 13.23 )
    -11.3 ( 6.47 )
    -12.5 ( 9.15 )
        Week 52
    -13.6 ( 9.11 )
    -11.9 ( 7.69 )
    -18.9 ( 10.74 )
    -13.0 ( 12.25 )
    -10.8 ( 5.53 )
    -12.2 ( 9.81 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Swollen Joint Count at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Swollen Joint Count at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    Swollen joint count is one of the specific components of the ACR Assessments used in this study which count the swollen joint based on 66 joints. The 66 joints to be assessed for swelling are the same as those listed above for tenderness assessment, except that the 2 hip joints are not included in the swollen joint count. The Baseline is defined as the measurements in Day 1. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -2.3 ( 3.48 )
    -2.7 ( 3.73 )
    -4.6 ( 5.46 )
    -2.1 ( 3.31 )
    -2.0 ( 3.82 )
    -2.0 ( 3.95 )
        Week 4
    -4.8 ( 4.42 )
    -4.3 ( 3.64 )
    -5.5 ( 5.51 )
    -5.2 ( 8.14 )
    -2.5 ( 3.11 )
    -3.6 ( 5.61 )
        Week 8
    -6.5 ( 5.42 )
    -5.9 ( 4.50 )
    -7.9 ( 4.72 )
    -7.5 ( 7.54 )
    -4.4 ( 5.42 )
    -4.4 ( 5.95 )
        Week 12
    -7.1 ( 5.89 )
    -6.7 ( 4.69 )
    -8.7 ( 6.97 )
    -8.7 ( 8.04 )
    -5.4 ( 5.26 )
    -4.7 ( 6.05 )
        Week 16
    -8.0 ( 5.53 )
    -7.6 ( 5.10 )
    -8.9 ( 7.94 )
    -9.9 ( 8.98 )
    -6.7 ( 5.80 )
    -5.5 ( 6.74 )
        Week 20
    -8.5 ( 5.31 )
    -8.3 ( 5.12 )
    -10.5 ( 8.42 )
    -10.8 ( 9.10 )
    -8.0 ( 6.29 )
    -7.6 ( 5.15 )
        Week 28
    -8.2 ( 4.34 )
    -7.7 ( 5.27 )
    -10.0 ( 7.66 )
    -10.9 ( 9.00 )
    -7.2 ( 5.79 )
    -8.5 ( 5.83 )
        Week 36
    -8.1 ( 4.35 )
    -8.1 ( 4.97 )
    -10.5 ( 7.55 )
    -11.1 ( 9.30 )
    -8.4 ( 5.60 )
    -8.9 ( 5.71 )
        Week 44
    -8.3 ( 4.87 )
    -8.2 ( 5.05 )
    -10.5 ( 6.84 )
    -10.8 ( 9.93 )
    -8.3 ( 5.57 )
    -9.5 ( 5.51 )
        Week 52
    -8.2 ( 4.84 )
    -8.1 ( 4.84 )
    -11.1 ( 7.68 )
    -10.7 ( 9.55 )
    -8.5 ( 5.76 )
    -9.2 ( 6.19 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient's Assessment of Arthritis Pain at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Patient's Assessment of Arthritis Pain at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    Patient's Assessment of Arthritis Pain is one of the specific components of the ACR Assessments used in this study. Subjects will assess the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. Rescaled VAS score is used. Rescaled VAS score (mm) = (100 mm) x (length at mark in mm/overall length of line in mm). The Baseline is defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Millimeter (mm)
    arithmetic mean (standard deviation)
        Week 2
    -7.6 ( 19.13 )
    -8.0 ( 17.96 )
    -5.3 ( 12.87 )
    1.7 ( 21.20 )
    -2.3 ( 11.89 )
    -9.0 ( 17.52 )
        Week 4
    -13.4 ( 23.39 )
    -18.5 ( 20.32 )
    -12.4 ( 22.60 )
    -7.9 ( 22.69 )
    -10.1 ( 18.67 )
    -9.6 ( 18.15 )
        Week 8
    -20.6 ( 23.55 )
    -21.0 ( 22.46 )
    -14.3 ( 27.34 )
    -10.7 ( 25.94 )
    -16.9 ( 22.67 )
    -13.1 ( 22.88 )
        Week 12
    -24.7 ( 25.72 )
    -22.8 ( 22.19 )
    -21.8 ( 24.25 )
    -14.9 ( 24.90 )
    -14.2 ( 24.54 )
    -12.3 ( 24.44 )
        Week 16
    -28.4 ( 24.13 )
    -25.0 ( 22.58 )
    -26.5 ( 23.41 )
    -30.2 ( 20.55 )
    -13.7 ( 22.14 )
    -14.6 ( 20.16 )
        Week 20
    -29.5 ( 24.12 )
    -30.9 ( 22.91 )
    -29.3 ( 24.07 )
    -25.5 ( 29.91 )
    -32.1 ( 22.84 )
    -27.7 ( 26.78 )
        Week 28
    -29.7 ( 22.88 )
    -32.2 ( 25.21 )
    -34.6 ( 21.85 )
    -35.2 ( 24.79 )
    -29.6 ( 27.49 )
    -37.4 ( 25.54 )
        Week 36
    -31.6 ( 25.14 )
    -31.3 ( 26.58 )
    -37.0 ( 29.87 )
    -33.5 ( 36.99 )
    -32.4 ( 21.11 )
    -38.5 ( 26.34 )
        Week 44
    -32.8 ( 26.90 )
    -36.5 ( 26.87 )
    -41.6 ( 16.12 )
    -34.1 ( 39.69 )
    -35.0 ( 23.36 )
    -40.0 ( 26.21 )
        Week 52
    -31.4 ( 26.39 )
    -35.5 ( 27.76 )
    -39.6 ( 21.95 )
    -34.9 ( 31.79 )
    -38.3 ( 22.84 )
    -38.5 ( 25.29 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient's Global Assessment of Arthritis at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Patient's Global Assessment of Arthritis at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    Patient's Global Assessment of Arthritis is one of the specific components of the ACR Assessments used in this study. Subjects will answer the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The subject’s response will be recorded using a 100 mm visual analog scale (VAS). Rescaled VAS score is used. Rescaled VAS score (mm) = (100 mm) x (length at mark in mm/overall length of line in mm). The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Millimeter (mm)
    arithmetic mean (standard deviation)
        Week 2
    -6.3 ( 21.52 )
    -10.9 ( 17.85 )
    -5.4 ( 17.59 )
    2.6 ( 19.66 )
    -0.1 ( 17.33 )
    -7.8 ( 17.02 )
        Week 4
    -14.4 ( 25.55 )
    -20.5 ( 20.60 )
    -12.3 ( 18.09 )
    -8.9 ( 16.46 )
    -2.0 ( 20.76 )
    -3.3 ( 17.34 )
        Week 8
    -19.4 ( 24.61 )
    -21.9 ( 24.29 )
    -14.0 ( 21.37 )
    -12.7 ( 19.88 )
    -11.0 ( 26.22 )
    -7.0 ( 22.38 )
        Week 12
    -21.8 ( 26.15 )
    -26.2 ( 21.18 )
    -20.0 ( 24.36 )
    -12.4 ( 21.29 )
    -12.2 ( 26.00 )
    -8.0 ( 25.46 )
        Week 16
    -27.8 ( 22.31 )
    -27.3 ( 21.62 )
    -26.1 ( 25.26 )
    -26.7 ( 19.05 )
    -9.3 ( 23.48 )
    -9.4 ( 21.11 )
        Week 20
    -26.8 ( 23.84 )
    -31.4 ( 21.81 )
    -27.6 ( 23.49 )
    -22.8 ( 31.26 )
    -28.8 ( 25.44 )
    -25.5 ( 24.96 )
        Week 28
    -29.4 ( 20.78 )
    -34.0 ( 23.87 )
    -33.9 ( 22.09 )
    -33.7 ( 23.46 )
    -31.7 ( 24.10 )
    -33.9 ( 23.79 )
        Week 36
    -30.1 ( 23.65 )
    -34.1 ( 26.03 )
    -37.2 ( 29.10 )
    -30.7 ( 39.29 )
    -28.5 ( 21.25 )
    -34.9 ( 24.80 )
        Week 44
    -31.5 ( 24.77 )
    -34.9 ( 24.41 )
    -38.2 ( 22.88 )
    -33.0 ( 39.17 )
    -28.7 ( 23.22 )
    -35.6 ( 26.55 )
        Week 52
    -32.0 ( 24.63 )
    -35.2 ( 28.60 )
    -36.8 ( 23.09 )
    -29.6 ( 32.56 )
    -34.9 ( 25.24 )
    -32.1 ( 28.85 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician's Global Assessment of Arthritis at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Physician's Global Assessment of Arthritis at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    Physician's Global Assessment of Arthritis is one of the specific components of the ACR Assessments used in this study. The blinded assessor will assess how the subject’s overall arthritis appears at the time of the visit. This is an evaluation based on the subject’s disease signs, functional capacity and physical examination, and should be independent of the Patient’s Global Assessment of Arthritis. The investigator’s response will be recorded using a 100 mm visual analog scale (VAS). Rescaled VAS score is used. Rescaled VAS score (mm) = (100 mm) x (length at mark in mm/overall length of line in mm). The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Millimeter (mm)
    arithmetic mean (standard deviation)
        Week 2
    -9.2 ( 15.59 )
    -9.0 ( 14.87 )
    -9.9 ( 14.55 )
    -1.9 ( 10.79 )
    -3.4 ( 11.92 )
    -7.2 ( 13.64 )
        Week 4
    -19.8 ( 18.98 )
    -17.6 ( 18.37 )
    -18.3 ( 22.31 )
    -11.1 ( 13.99 )
    -8.8 ( 17.67 )
    -9.5 ( 18.08 )
        Week 8
    -30.6 ( 19.43 )
    -25.0 ( 18.02 )
    -28.7 ( 15.73 )
    -16.4 ( 21.08 )
    -16.3 ( 20.97 )
    -11.9 ( 17.94 )
        Week 12
    -35.2 ( 19.92 )
    -30.1 ( 16.85 )
    -31.1 ( 20.62 )
    -21.2 ( 22.01 )
    -16.5 ( 21.57 )
    -13.7 ( 22.30 )
        Week 16
    -37.7 ( 20.59 )
    -33.7 ( 17.89 )
    -31.2 ( 20.00 )
    -32.5 ( 23.98 )
    -16.5 ( 23.34 )
    -14.4 ( 27.76 )
        Week 20
    -41.8 ( 19.91 )
    -37.8 ( 19.48 )
    -38.7 ( 24.67 )
    -34.7 ( 26.16 )
    -31.0 ( 22.29 )
    -27.1 ( 25.41 )
        Week 28
    -42.0 ( 21.42 )
    -36.7 ( 21.91 )
    -47.6 ( 21.44 )
    -42.4 ( 23.28 )
    -32.7 ( 22.03 )
    -38.8 ( 20.53 )
        Week 36
    -42.7 ( 22.92 )
    -36.8 ( 23.05 )
    -46.3 ( 22.42 )
    -43.4 ( 20.30 )
    -38.0 ( 19.52 )
    -42.6 ( 20.41 )
        Week 44
    -44.5 ( 20.15 )
    -40.6 ( 22.19 )
    -51.9 ( 15.81 )
    -43.2 ( 25.55 )
    -36.4 ( 20.54 )
    -44.9 ( 20.40 )
        Week 52
    -46.6 ( 21.73 )
    -43.4 ( 20.36 )
    -54.1 ( 15.18 )
    -42.7 ( 23.34 )
    -36.3 ( 21.01 )
    -41.9 ( 22.66 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The HAQ DI is one of the specific components of the ACR Assessments used in this study. The HAQ DI assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 23 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as “unable to do”. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.133 ( 0.4273 )
    -0.177 ( 0.3489 )
    -0.195 ( 0.2886 )
    -0.117 ( 0.4212 )
    -0.030 ( 0.4572 )
    -0.170 ( 0.3091 )
        Week 4
    -0.248 ( 0.5341 )
    -0.315 ( 0.3777 )
    -0.180 ( 0.2090 )
    -0.217 ( 0.3356 )
    -0.095 ( 0.4931 )
    -0.170 ( 0.3305 )
        Week 8
    -0.343 ( 0.5690 )
    -0.421 ( 0.4103 )
    -0.188 ( 0.4472 )
    -0.277 ( 0.3609 )
    -0.184 ( 0.4959 )
    -0.249 ( 0.4465 )
        Week 12
    -0.366 ( 0.5701 )
    -0.478 ( 0.4167 )
    -0.214 ( 0.4230 )
    -0.304 ( 0.2930 )
    -0.121 ( 0.4910 )
    -0.239 ( 0.4660 )
        Week 16
    -0.474 ( 0.5158 )
    -0.509 ( 0.3994 )
    -0.321 ( 0.3914 )
    -0.375 ( 0.3385 )
    -0.109 ( 0.5271 )
    -0.246 ( 0.3729 )
        Week 20
    -0.466 ( 0.5546 )
    -0.576 ( 0.4906 )
    -0.404 ( 0.4681 )
    -0.308 ( 0.4610 )
    -0.363 ( 0.4983 )
    -0.472 ( 0.4934 )
        Week 28
    -0.524 ( 0.5412 )
    0.583 ( 0.5262 )
    -0.519 ( 0.4531 )
    -0.490 ( 0.5064 )
    -0.422 ( 0.4811 )
    -0.517 ( 0.5520 )
        Week 36
    -0.520 ( 0.6051 )
    -0.594 ( 0.4990 )
    -0.577 ( 0.5740 )
    -0.519 ( 0.5633 )
    -0.329 ( 0.3816 )
    -0.547 ( 0.5867 )
        Week 44
    -0.521 ( 0.6197 )
    -0.581 ( 0.5321 )
    -0.563 ( 0.3830 )
    -0.510 ( 0.5576 )
    -0.370 ( 0.4210 )
    -0.576 ( 0.5757 )
        Week 52
    -0.503 ( 0.6023 )
    -0.567 ( 0.4866 )
    -0.500 ( 0.5137 )
    -0.552 ( 0.5041 )
    -0.411 ( 0.3695 )
    -0.514 ( 0.5704 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in High Sensitivity C-reactive Protein (hsCRP) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change from Baseline in High Sensitivity C-reactive Protein (hsCRP) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    C-reactive protein (hsCRP) is one of the specific components of the ACR Assessments used in this study. Blood samples for determination of hsCRP were obtained at the times specified above. The Baseline is defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: milligram per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 2
    -4.420 ( 8.9409 )
    -3.696 ( 11.9628 )
    -6.023 ( 19.1126 )
    -0.595 ( 1.4661 )
    -1.641 ( 10.4224 )
    1.462 ( 7.8966 )
        Week 4
    -3.645 ( 11.8144 )
    -5.543 ( 11.9617 )
    -6.134 ( 19.5633 )
    -1.324 ( 1.9735 )
    0.010 ( 7.0206 )
    1.206 ( 5.4423 )
        Week 8
    -3.828 ( 10.8093 )
    -5.102 ( 11.5408 )
    -6.029 ( 19.9534 )
    -0.573 ( 2.6595 )
    -2.598 ( 10.7270 )
    0.927 ( 6.2062 )
        Week 12
    -3.759 ( 11.0481 )
    -5.881 ( 12.9484 )
    -7.335 ( 22.0149 )
    -1.177 ( 3.4854 )
    -1.061 ( 11.1944 )
    1.021 ( 6.6025 )
        Week 16
    -3.695 ( 8.1064 )
    -5.809 ( 13.6463 )
    -5.420 ( 21.9622 )
    1.060 ( 8.7842 )
    -2.218 ( 11.6164 )
    -0.762 ( 6.5779 )
        Week 20
    -4.581 ( 10.5026 )
    -6.014 ( 14.7723 )
    -7.879 ( 24.2763 )
    -0.989 ( 3.6969 )
    -5.982 ( 10.4711 )
    -4.718 ( 7.1896 )
        Week 28
    -4.277 ( 12.9069 )
    -6.362 ( 13.6372 )
    -8.679 ( 24.9759 )
    -1.300 ( 3.7971 )
    -6.112 ( 10.6756 )
    -5.484 ( 10.0475 )
        Week 36
    -4.899 ( 10.3015 )
    -5.940 ( 14.4219 )
    -9.461 ( 25.7767 )
    -1.814 ( 3.0658 )
    -6.247 ( 9.8145 )
    -5.029 ( 9.1947 )
        Week 44
    -5.543 ( 11.7058 )
    -6.215 ( 14.2493 )
    -2.196 ( 2.2859 )
    -0.987 ( 3.7325 )
    -4.690 ( 9.9495 )
    -0.711 ( 13.7530 )
        Week 52
    -5.167 ( 13.3963 )
    -4.880 ( 14.1148 )
    -1.586 ( 3.0576 )
    -2.028 ( 3.2177 )
    -4.324 ( 7.7335 )
    -4.722 ( 9.3318 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The PASI quantifies the severity of a subject's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 indicates a 75% or greater reduction in PASI scores from baseline. Number of subjects analyzed: subjects who had baseline BSA>=3% and PASI>0 and had response.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    40
    39
    12
    9
    22
    19
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 2
    5.00 (0.00 to 11.75)
    2.56 (0.00 to 7.52)
    3.85 (0.00 to 14.30)
    11.11 (0.00 to 31.64)
    2.17 (0.00 to 8.13)
    5.26 (0.00 to 15.30)
        Week 4
    30.00 (15.80 to 44.20)
    12.82 (2.33 to 23.31)
    3.85 (0.00 to 14.30)
    11.11 (0.00 to 31.64)
    4.55 (0.00 to 13.25)
    5.26 (0.00 to 15.30)
        Week 8
    45.00 (29.58 to 60.42)
    41.03 (25.59 to 56.46)
    25.00 (0.50 to 49.50)
    11.11 (0.00 to 31.64)
    9.09 (0.00 to 21.10)
    15.79 (0.00 to 32.19)
        Week 12
    60.00 (44.82 to 75.18)
    48.72 (33.03 to 64.41)
    33.33 (6.66 to 60.01)
    33.33 (2.54 to 64.13)
    18.18 (2.06 to 34.30)
    21.05 (2.72 to 39.38)
        Week 16
    69.23 (54.75 to 83.72)
    58.97 (43.54 to 74.41)
    58.33 (30.44 to 86.23)
    55.56 (23.09 to 88.02)
    22.73 (5.22 to 40.24)
    26.32 (6.52 to 46.12)
        Week 20
    72.50 (58.66 to 86.34)
    61.54 (46.27 to 76.81)
    66.67 (39.99 to 93.34)
    55.56 (23.09 to 88.02)
    54.55 (33.74 to 75.35)
    36.84 (15.15 to 58.53)
        Week 28
    70.00 (55.80 to 84.20)
    51.28 (35.59 to 66.97)
    91.67 (76.03 to 100.00)
    77.78 (50.62 to 100.00)
    63.64 (43.54 to 83.74)
    63.16 (41.47 to 84.85)
        Week 36
    70.00 (55.80 to 84.20)
    64.10 (49.05 to 79.16)
    96.15 (85.70 to 100.00)
    88.89 (68.36 to 100.00)
    59.09 (38.55 to 79.64)
    47.37 (24.92 to 69.82)
        Week 44
    75.00 (61.58 to 88.42)
    66.67 (51.87 to 81.46)
    75.00 (50.50 to 99.50)
    55.56 (23.09 to 88.02)
    63.64 (43.54 to 83.74)
    63.16 (41.47 to 84.85)
        Week 52
    65.00 (50.22 to 79.78)
    66.67 (51.87 to 81.46)
    66.67 (39.99 to 93.34)
    66.67 (35.87 to 97.46)
    50.00 (29.11 to 70.89)
    57.89 (35.69 to 80.10)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a PASI 90 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving a PASI 90 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The PASI quantifies the severity of a subject's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 indicates a 90% or greater reduction in PASI scores from baseline. Number of subjects analyzed: subjects who had baseline BSA>=3% and PASI>0 and had response.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    40
    39
    12
    9
    22
    19
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 2
    1.22 (0.00 to 4.58)
    1.25 (0.00 to 4.69)
    3.85 (0.00 to 14.30)
    11.11 (0.00 to 31.64)
    2.17 (0.00 to 8.13)
    2.50 (0.00 to 9.34)
        Week 4
    17.50 (5.72 to 29.28)
    5.13 (0.00 to 12.05)
    3.85 (0.00 to 14.30)
    11.11 (0.00 to 31.64)
    4.55 (0.00 to 13.25)
    2.50 (0.00 to 9.34)
        Week 8
    35.00 (20.22 to 49.78)
    17.95 (5.90 to 29.99)
    16.67 (0.00 to 37.75)
    11.11 (0.00 to 31.64)
    2.17 (0.00 to 8.13)
    5.26 (0.00 to 15.30)
        Week 12
    47.50 (32.02 to 62.98)
    25.64 (11.94 to 39.35)
    16.67 (0.00 to 37.75)
    22.22 (0.00 to 49.38)
    2.17 (0.00 to 8.13)
    10.53 (0.00 to 24.33)
        Week 16
    53.85 (38.20 to 69.49)
    33.33 (18.54 to 48.13)
    33.33 (6.66 to 60.01)
    33.33 (2.54 to 64.13)
    9.09 (0.00 to 21.10)
    15.79 (0.00 to 32.19)
        Week 20
    50.00 (34.51 to 65.49)
    43.59 (28.03 to 59.15)
    50.00 (21.71 to 78.29)
    44.44 (11.98 to 76.91)
    18.18 (2.06 to 34.30)
    26.32 (6.52 to 46.12)
        Week 28
    52.50 (37.02 to 67.98)
    38.46 (23.19 to 53.73)
    58.33 (30.44 to 86.23)
    44.44 (11.98 to 76.91)
    50.00 (29.11 to 70.89)
    31.58 (10.68 to 52.48)
        Week 36
    62.50 (47.50 to 77.50)
    48.72 (33.03 to 64.41)
    83.33 (62.25 to 100.00)
    66.67 (35.87 to 97.46)
    45.45 (24.65 to 66.26)
    36.84 (15.15 to 58.53)
        Week 44
    52.50 (37.02 to 67.98)
    48.72 (33.03 to 64.41)
    66.67 (39.99 to 93.34)
    44.44 (11.98 to 76.91)
    50.00 (29.11 to 70.89)
    52.63 (30.18 to 75.08)
        Week 52
    40.00 (24.82 to 55.18)
    56.41 (40.85 to 71.97)
    66.67 (39.99 to 93.34)
    55.56 (23.09 to 88.02)
    45.45 (24.65 to 66.26)
    47.37 (24.92 to 69.82)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a PASI 100 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving a PASI 100 Response at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The PASI quantifies the severity of a subject's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. Assessments of lesion Severity Score and Area Score are performed separately for each of the four body regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). In each body region, the sum of the lesion Severity Scores for erythema, induration and scaling is multiplied by the Area Score which represents the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 indicates a 100% or greater reduction in PASI scores from baseline. Number of subjects analyzed: subjects who had baseline BSA>=3% and PASI>0 and had response.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    40
    39
    12
    9
    22
    19
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 2
    1.22 (0.00 to 4.58)
    1.25 (0.00 to 4.69)
    3.85 (0.00 to 14.30)
    11.11 (0.00 to 31.64)
    2.17 (0.00 to 8.13)
    2.50 (0.00 to 9.34)
        Week 4
    7.50 (0.00 to 15.66)
    1.25 (0.00 to 4.69)
    3.85 (0.00 to 14.30)
    5.00 (0.00 to 18.51)
    4.55 (0.00 to 13.25)
    2.50 (0.00 to 9.34)
        Week 8
    20.00 (7.60 to 32.40)
    5.13 (0.00 to 12.05)
    8.33 (0.00 to 23.97)
    11.11 (0.00 to 31.64)
    2.17 (0.00 to 8.13)
    2.50 (0.00 to 9.34)
        Week 12
    35.00 (20.22 to 49.78)
    7.69 (0.00 to 16.06)
    8.33 (0.00 to 23.97)
    11.11 (0.00 to 31.64)
    2.17 (0.00 to 8.13)
    5.26 (0.00 to 15.30)
        Week 16
    35.90 (20.84 to 50.95)
    15.38 (4.06 to 26.71)
    16.67 (0.00 to 37.75)
    33.33 (2.54 to 64.13)
    9.09 (0.00 to 21.10)
    10.53 (0.00 to 24.33)
        Week 20
    27.50 (13.66 to 41.34)
    35.90 (20.84 to 50.95)
    33.33 (6.66 to 60.01)
    44.44 (11.98 to 76.91)
    13.64 (0.00 to 27.98)
    10.53 (0.00 to 24.33)
        Week 28
    35.00 (20.22 to 49.78)
    30.77 (16.28 to 45.25)
    50.00 (21.71 to 78.29)
    44.44 (11.98 to 76.91)
    40.91 (20.36 to 61.45)
    21.05 (2.72 to 39.38)
        Week 36
    40.00 (24.82 to 55.18)
    35.90 (20.84 to 50.95)
    50.00 (21.71 to 78.29)
    55.56 (23.09 to 88.02)
    36.36 (16.26 to 56.46)
    21.05 (2.72 to 39.38)
        Week 44
    30.00 (15.80 to 44.20)
    41.03 (25.59 to 56.46)
    58.33 (30.44 to 86.23)
    44.44 (11.98 to 76.91)
    31.82 (12.36 to 51.28)
    42.11 (19.90 to 64.31)
        Week 52
    35.00 (20.22 to 49.78)
    38.46 (23.19 to 53.73)
    41.67 (13.77 to 69.56)
    33.33 (2.54 to 64.13)
    36.36 (16.26 to 56.46)
    42.11 (19.90 to 64.31)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The SPARCC Enthesitis Index examines tenderness at sixteen sites: medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle (considered 1 site for scoring purposes), Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. Each site is classified on a dichotomous basis as either tender (score=1) or not tender (score=0). The SPARCC Enthesitis Index scores range from 0‑16, with higher scores indicating higher disease activity. The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: subjects available in the evaluable population (subjects who were randomized to the study and received at least one dose of the randomized study treatment) at the specified treatment timepoints with baseline SPARCC enthesitis score>0.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    38
    34
    11
    9
    21
    19
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.6 ( 1.55 )
    -0.3 ( 2.73 )
    -1.4 ( 1.86 )
    0.0 ( 1.12 )
    -0.2 ( 1.79 )
    -0.3 ( 2.67 )
        Week 4
    -1.4 ( 2.41 )
    -0.9 ( 2.32 )
    -1.3 ( 2.37 )
    0.0 ( 1.41 )
    -1.0 ( 2.29 )
    -1.0 ( 2.81 )
        Week 8
    -1.9 ( 2.11 )
    -1.9 ( 2.23 )
    -1.4 ( 1.80 )
    -1.0 ( 1.07 )
    -1.1 ( 2.50 )
    -1.2 ( 2.53 )
        Week 12
    -2.1 ( 2.49 )
    -1.6 ( 2.22 )
    -2.7 ( 1.73 )
    -1.3 ( 1.04 )
    -1.7 ( 2.52 )
    -1.1 ( 3.00 )
        Week 16
    -2.1 ( 2.68 )
    -1.3 ( 1.89 )
    -3.1 ( 1.27 )
    -0.3 ( 2.71 )
    -1.8 ( 2.94 )
    -1.2 ( 2.79 )
        Week 20
    -2.3 ( 2.66 )
    -1.9 ( 2.29 )
    -3.2 ( 3.03 )
    -1.3 ( 0.89 )
    -2.1 ( 2.24 )
    -1.9 ( 2.71 )
        Week 28
    -2.4 ( 2.68 )
    -2.3 ( 2.60 )
    -3.8 ( 2.05 )
    -1.4 ( 1.19 )
    -2.5 ( 2.97 )
    -3.1 ( 2.60 )
        Week 36
    -2.6 ( 2.70 )
    -2.3 ( 2.28 )
    -3.8 ( 1.79 )
    -1.6 ( 1.06 )
    -2.1 ( 2.51 )
    -2.8 ( 2.60 )
        Week 44
    -2.9 ( 2.56 )
    -2.4 ( 2.53 )
    -3.3 ( 1.67 )
    -1.6 ( 1.06 )
    -2.1 ( 2.57 )
    -3.2 ( 2.44 )
        Week 52
    -3.1 ( 2.55 )
    -2.4 ( 2.34 )
    -4.8 ( 2.76 )
    -1.5 ( 0.76 )
    -2.2 ( 1.74 )
    -3.6 ( 2.59 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at All Treatment Timepoints: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The Leeds Enthesitis Index (LEI) examines tenderness at six sites: lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Each site is assessed as either tender (score=1) or not tender (score=0). The LEI scores range from 0‑6, with higher scores indicating higher disease activity. The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: subjects available in the evaluable population (subjects who were randomized to the study and received at least one dose of the randomized study treatment) at the specified treatment timepoints with baseline leeds enthesitis score>0.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    29
    28
    10
    8
    20
    15
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.4 ( 0.95 )
    -0.4 ( 1.53 )
    -0.5 ( 1.27 )
    0.0 ( 0.53 )
    -0.1 ( 1.12 )
    -0.3 ( 0.82 )
        Week 4
    -0.7 ( 1.56 )
    -0.9 ( 1.48 )
    -1.0 ( 1.25 )
    -0.1 ( 0.99 )
    -0.4 ( 0.75 )
    -0.9 ( 1.62 )
        Week 8
    -1.3 ( 1.43 )
    -1.2 ( 1.47 )
    -0.5 ( 1.78 )
    -0.4 ( 0.98 )
    -0.5 ( 1.31 )
    -0.7 ( 1.49 )
        Week 12
    -1.2 ( 1.93 )
    -1.5 ( 1.42 )
    -1.0 ( 1.22 )
    -1.1 ( 0.90 )
    -0.9 ( 0.94 )
    -0.9 ( 1.79 )
        Week 16
    -1.4 ( 1.63 )
    -1.5 ( 1.45 )
    -1.2 ( 0.83 )
    -0.1 ( 2.12 )
    -0.9 ( 1.13 )
    -0.9 ( 1.54 )
        Week 20
    -1.6 ( 1.52 )
    -1.3 ( 1.80 )
    -1.7 ( 2.65 )
    -0.9 ( 0.90 )
    -1.1 ( 0.90 )
    -1.4 ( 1.91 )
        Week 28
    -1.4 ( 1.56 )
    -1.7 ( 1.57 )
    -1.9 ( 2.20 )
    -1.3 ( 0.76 )
    -1.1 ( 1.20 )
    -1.7 ( 1.54 )
        Week 36
    -1.9 ( 1.36 )
    -1.8 ( 1.59 )
    -2.3 ( 1.50 )
    -1.1 ( 0.90 )
    -1.1 ( 1.17 )
    -1.7 ( 1.44 )
        Week 44
    -1.8 ( 1.47 )
    -1.8 ( 1.65 )
    -2.3 ( 1.04 )
    -1.3 ( 0.76 )
    -1.2 ( 1.19 )
    -1.9 ( 1.41 )
        Week 52
    -2.0 ( 1.54 )
    -1.7 ( 1.40 )
    -2.5 ( 0.93 )
    -1.0 ( 0.82 )
    -1.2 ( 0.73 )
    -1.8 ( 1.70 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Dactylitis Severity Score (DSS) at all treatment time points: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in Dactylitis Severity Score (DSS) at all treatment time points: Week 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The number of digits in hands and feet with dactylitis was evaluated by a blinded assessor. In addition, dactylitis severity was scored based upon digit tenderness using a scale of 0‑3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet. The range of total dactylitis scores for a subject would be 0‑60. The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: subjects available in the evaluable population (subject who were randomized to the study and received at least one dose of the randomized study treatment) at the specified treatment timepoints with baseline DSS >0.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    14
    19
    3
    6
    12
    9
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.2 ( 2.36 )
    -0.7 ( 2.54 )
    -2.7 ( 4.62 )
    -0.5 ( 1.38 )
    -0.7 ( 1.61 )
    0.2 ( 2.28 )
        Week 4
    -1.6 ( 3.30 )
    -2.2 ( 3.15 )
    -3.3 ( 3.21 )
    -0.8 ( 1.17 )
    -1.2 ( 2.59 )
    -0.3 ( 3.12 )
        Week 8
    -3.5 ( 4.31 )
    -4.0 ( 3.22 )
    -4.3 ( 4.16 )
    -1.7 ( 1.37 )
    -2.5 ( 6.14 )
    -1.8 ( 2.82 )
        Week 12
    -4.4 ( 3.34 )
    -4.5 ( 3.30 )
    -4.3 ( 4.93 )
    -3.2 ( 3.43 )
    -4.8 ( 7.07 )
    -2.8 ( 4.49 )
        Week 16
    -3.7 ( 3.85 )
    -4.9 ( 4.06 )
    -4.7 ( 6.35 )
    -3.7 ( 4.13 )
    -5.4 ( 7.44 )
    -2.9 ( 6.01 )
        Week 20
    -4.4 ( 3.31 )
    -4.6 ( 4.23 )
    -5.3 ( 5.86 )
    -3.7 ( 4.13 )
    -7.0 ( 7.44 )
    -4.4 ( 6.11 )
        Week 28
    -3.8 ( 3.67 )
    -5.1 ( 4.08 )
    -5.3 ( 5.86 )
    -3.7 ( 4.13 )
    -6.6 ( 7.18 )
    -4.7 ( 7.05 )
        Week 36
    -4.2 ( 4.02 )
    -5.1 ( 4.26 )
    -5.7 ( 5.69 )
    -3.7 ( 4.13 )
    -6.8 ( 7.34 )
    -5.3 ( 7.40 )
        Week 44
    -5.0 ( 3.65 )
    -5.4 ( 4.01 )
    -5.7 ( 5.69 )
    -3.7 ( 4.13 )
    -6.8 ( 7.34 )
    -5.3 ( 7.40 )
        Week 52
    -5.0 ( 3.65 )
    -5.4 ( 4.05 )
    -5.7 ( 5.69 )
    -3.7 ( 4.13 )
    -5.0 ( 5.40 )
    -5.7 ( 8.62 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at All Treatment Timepoints: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at All Treatment Timepoints: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    A target finger nail was evaluated by the blinded assessor using the NAPSI scale. At the baseline visit, the worst case fingernail should be chosen and the same nail evaluated consistently through the entire study. Each quadrant of the target nail was graded for nail matrix psoriasis (including any of the following parameters: pitting, leukonychia, red spots in lunula, nail plate crumbling) and nail bed psoriasis (including any of the following parameters: onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, nail bed hyperkeratosis), giving that 1 target nail a score of 0‑8 directionality. The Baseline is defined as the measurements in Day 1. Number of subjects analyzed: subjects available in the evaluable population (subject who were randomized to the study and received at least one dose of the randomized study treatment) at the specified treatment timepoints with baseline NAPSI >0.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    36
    40
    10
    8
    25
    16
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.4 ( 1.55 )
    0.1 ( 0.65 )
    -0.4 ( 0.52 )
    0.3 ( 0.71 )
    -0.2 ( 1.04 )
    0.1 ( 0.25 )
        Week 4
    -1.0 ( 2.09 )
    -0.5 ( 1.70 )
    -0.9 ( 1.10 )
    -0.3 ( 0.46 )
    -1.0 ( 2.16 )
    -0.3 ( 0.95 )
        Week 8
    -2.0 ( 2.40 )
    -1.0 ( 1.49 )
    -1.1 ( 1.52 )
    -1.1 ( 1.57 )
    -1.3 ( 2.55 )
    -0.6 ( 1.55 )
        Week 12
    -2.8 ( 2.54 )
    -1.8 ( 2.43 )
    -0.5 ( 2.88 )
    -1.9 ( 2.97 )
    -1.2 ( 2.62 )
    -1.3 ( 1.82 )
        Week 16
    -3.2 ( 2.71 )
    -1.7 ( 2.54 )
    -1.5 ( 2.00 )
    -2.9 ( 3.08 )
    -1.4 ( 2.61 )
    -1.6 ( 1.76 )
        Week 20
    -3.7 ( 2.82 )
    -2.3 ( 2.31 )
    -2.1 ( 2.41 )
    -3.1 ( 2.97 )
    -2.0 ( 2.61 )
    -1.9 ( 1.81 )
        Week 28
    -3.9 ( 2.90 )
    -2.4 ( 2.56 )
    -3.1 ( 2.12 )
    -3.3 ( 2.93 )
    -2.2 ( 2.59 )
    -2.5 ( 1.83 )
        Week 36
    -3.9 ( 3.06 )
    -2.5 ( 2.51 )
    -3.3 ( 1.98 )
    -3.3 ( 3.15 )
    -2.8 ( 2.71 )
    -2.9 ( 1.75 )
        Week 44
    -4.2 ( 2.77 )
    -2.8 ( 2.47 )
    -4.2 ( 2.05 )
    -3.8 ( 3.19 )
    -2.8 ( 2.61 )
    -2.6 ( 1.71 )
        Week 52
    -4.2 ( 2.62 )
    -2.6 ( 2.80 )
    -3.6 ( 2.07 )
    -3.7 ( 3.27 )
    -3.1 ( 2.91 )
    -2.7 ( 1.30 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Patient’s Global Joint and Skin Assessment‑Visual Analog Scale (PGJS‑VAS) at All Treatment Timepoints: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Patient’s Global Joint and Skin Assessment‑Visual Analog Scale (PGJS‑VAS) at All Treatment Timepoints: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    Subject's perception of disease was assessed using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (excellent) and 100 (poor). The rating corresponds to the way in which the subject felt over the past week in terms of how they were affected by their: 1) psoriasis and arthritis (global, PGA); 2) arthritis only (PJA) and 3) psoriasis only (PSA). Rescaled VAS score is used. Rescaled VAS score (mm) = (100 mm) x (length at mark in mm/overall length of line in mm). The Baseline is defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: millimeter (mm)
    arithmetic mean (standard deviation)
        Week 2
    -8.9 ( 26.88 )
    -11.6 ( 22.31 )
    -4.9 ( 12.42 )
    -0.5 ( 12.41 )
    -3.3 ( 14.50 )
    -7.1 ( 17.44 )
        Week 4
    -17.0 ( 24.93 )
    -18.8 ( 25.42 )
    -13.2 ( 18.69 )
    -7.1 ( 21.61 )
    -11.6 ( 22.07 )
    -6.2 ( 24.53 )
        Week 8
    -21.1 ( 26.95 )
    -19.7 ( 27.56 )
    -12.0 ( 26.52 )
    -16.4 ( 25.36 )
    -16.8 ( 26.21 )
    -8.1 ( 24.41 )
        Week 12
    -25.1 ( 28.18 )
    -25.3 ( 23.75 )
    -18.0 ( 21.42 )
    -17.6 ( 23.70 )
    -14.4 ( 28.78 )
    -9.5 ( 23.74 )
        Week 16
    -29.0 ( 24.78 )
    -24.5 ( 25.43 )
    -23.9 ( 21.10 )
    -27.8 ( 21.23 )
    -11.7 ( 23.36 )
    -9.9 ( 23.87 )
        Week 20
    -29.1 ( 24.08 )
    -30.5 ( 23.29 )
    -27.3 ( 24.19 )
    -22.6 ( 27.92 )
    -36.3 ( 22.12 )
    -26.3 ( 29.72 )
        Week 28
    -30.0 ( 24.53 )
    -29.7 ( 28.36 )
    -37.2 ( 22.80 )
    -38.8 ( 25.73 )
    -37.3 ( 25.35 )
    -37.2 ( 24.64 )
        Week 36
    -29.1 ( 27.81 )
    -29.6 ( 27.90 )
    -42.0 ( 26.37 )
    -33.7 ( 27.04 )
    -36.0 ( 22.02 )
    -39.4 ( 26.35 )
        Week 44
    -33.6 ( 28.52 )
    -32.4 ( 28.81 )
    -41.9 ( 19.08 )
    -36.8 ( 30.62 )
    -38.2 ( 26.65 )
    -42.1 ( 27.08 )
        Week 52
    -33.3 ( 28.68 )
    -32.7 ( 29.77 )
    -35.6 ( 26.94 )
    -33.9 ( 33.45 )
    -39.1 ( 23.78 )
    -38.3 ( 30.58 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Functional Assessment of Chronic Illness Therapy‑Fatigue (FACIT‑F) at All Treatment Timepoints: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Functional Assessment of Chronic Illness Therapy‑Fatigue (FACIT‑F) at All Treatment Timepoints: Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items of Q1 I feel fatigued, Q2 I feel weak all over, Q3 I feel listless (“washed out”), Q4 I feel tired and Q7 I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the score. In cases where some answers are missing, a total score is prorated from the score of the answered items, so long as more than 50% of the items (i.e., at least 7 of 13 for FACIT-F total score, at least 3 of 5 for FACIT-F experience domain score, and at least 5 of 8 for FACIT-F impact domain score) are answered. The Baseline is defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 2
    2.0 ( 5.82 )
    3.1 ( 5.85 )
    0.9 ( 2.60 )
    1.2 ( 6.45 )
    0.9 ( 6.95 )
    2.7 ( 6.07 )
        Week 4
    2.4 ( 7.47 )
    5.7 ( 7.34 )
    3.7 ( 5.40 )
    3.7 ( 8.30 )
    3.0 ( 10.76 )
    2.5 ( 6.98 )
        Week 8
    4.2 ( 8.03 )
    5.6 ( 8.44 )
    3.6 ( 5.78 )
    3.8 ( 6.24 )
    3.2 ( 10.31 )
    3.7 ( 9.92 )
        Week 12
    4.7 ( 10.17 )
    7.3 ( 7.96 )
    3.2 ( 4.10 )
    6.1 ( 7.85 )
    5.5 ( 9.55 )
    3.8 ( 9.85 )
        Week 16
    5.6 ( 7.74 )
    7.1 ( 9.41 )
    4.4 ( 5.40 )
    6.0 ( 6.89 )
    4.7 ( 8.10 )
    4.7 ( 8.99 )
        Week 20
    6.6 ( 8.69 )
    9.5 ( 8.20 )
    7.2 ( 5.86 )
    7.0 ( 7.94 )
    8.9 ( 8.11 )
    9.3 ( 9.20 )
        Week 28
    7.7 ( 9.67 )
    9.5 ( 8.22 )
    7.2 ( 7.73 )
    12.3 ( 11.48 )
    9.8 ( 10.02 )
    11.7 ( 10.41 )
        Week 36
    7.4 ( 9.51 )
    8.4 ( 8.25 )
    7.3 ( 5.54 )
    10.6 ( 11.36 )
    9.6 ( 6.48 )
    11.3 ( 11.23 )
        Week 44
    7.8 ( 9.00 )
    10.0 ( 9.52 )
    7.9 ( 5.07 )
    13.1 ( 11.10 )
    7.7 ( 7.89 )
    11.8 ( 11.35 )
        Week 52
    7.8 ( 8.54 )
    10.4 ( 9.86 )
    9.4 ( 9.01 )
    12.3 ( 12.74 )
    10.5 ( 8.91 )
    10.5 ( 10.62 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Short‑Form‑36 Health Survey (SF‑36) Version 2, Acute at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Short‑Form‑36 Health Survey (SF‑36) Version 2, Acute at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). These domains can also be summarized as physical and mental component scores. The summary component scores are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH. All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The Baseline is defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 4
    3.29 ( 7.092 )
    4.24 ( 7.602 )
    2.59 ( 5.263 )
    1.01 ( 3.944 )
    1.66 ( 5.845 )
    2.64 ( 6.299 )
        Week 8
    4.21 ( 8.297 )
    5.97 ( 8.261 )
    5.53 ( 9.387 )
    2.47 ( 3.675 )
    2.57 ( 6.457 )
    3.04 ( 6.529 )
        Week 12
    4.09 ( 8.403 )
    4.86 ( 9.010 )
    7.28 ( 7.232 )
    2.29 ( 4.283 )
    2.22 ( 6.205 )
    3.07 ( 7.330 )
        Week 16
    5.40 ( 8.239 )
    7.27 ( 8.627 )
    6.97 ( 7.223 )
    5.07 ( 4.763 )
    2.36 ( 6.842 )
    1.79 ( 6.101 )
        Week 20
    4.75 ( 8.579 )
    8.84 ( 8.231 )
    9.53 ( 8.434 )
    2.03 ( 6.756 )
    6.14 ( 7.513 )
    6.25 ( 8.447 )
        Week 28
    6.16 ( 8.691 )
    9.06 ( 9.597 )
    9.42 ( 7.751 )
    7.84 ( 7.127 )
    5.67 ( 7.933 )
    9.22 ( 8.890 )
        Week 36
    6.58 ( 9.510 )
    7.75 ( 9.233 )
    9.08 ( 9.789 )
    6.44 ( 7.245 )
    5.96 ( 6.738 )
    9.41 ( 8.940 )
        Week 44
    6.67 ( 9.541 )
    9.23 ( 9.477 )
    8.44 ( 9.527 )
    7.13 ( 6.759 )
    6.00 ( 6.937 )
    9.18 ( 8.199 )
        Week 52
    6.52 ( 9.818 )
    9.98 ( 9.150 )
    9.55 ( 9.536 )
    6.64 ( 7.925 )
    7.21 ( 8.130 )
    9.84 ( 9.347 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Minimal Disease Activity (MDA) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving Minimal Disease Activity (MDA) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    A psoriatic arthritis subject was defined as having MDA response when 5 of the 7 following criteria were met: 1) tender joint count ≤1; 2) swollen joint count ≤1; 3) PASI score ≤1 or BSA ≤3%; 4) subject Arthritis Pain (VAS) ≤15 mm; 5) participant's global arthritis assessment (VAS) ≤20 mm; 6) HAQ-DI score ≤0.5; 7) tender entheseal points (using Leed’s enthesitis Index) ≤1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4
    8.33 (1.34 to 15.33)
    8.33 (1.34 to 15.33)
    6.25 (0.00 to 18.11)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    3.03 (0.00 to 8.88)
        Week 8
    26.67 (15.48 to 37.86)
    21.67 (11.24 to 32.09)
    18.75 (0.00 to 37.87)
    6.67 (0.00 to 19.29)
    5.88 (0.00 to 13.79)
    12.12 (0.99 to 23.26)
        Week 12
    31.67 (19.90 to 43.44)
    25.00 (14.04 to 35.96)
    18.75 (0.00 to 37.87)
    20.00 (0.00 to 40.24)
    5.88 (0.00 to 13.79)
    12.12 (0.99 to 23.26)
        Week 16
    35.59 (23.38 to 47.81)
    35.00 (22.93 to 47.07)
    18.75 (0.00 to 37.87)
    20.00 (0.00 to 40.24)
    2.94 (0.00 to 8.62)
    3.03 (0.00 to 8.88)
        Week 20
    45.00 (32.41 to 57.59)
    38.33 (26.03 to 50.64)
    25.00 (3.78 to 46.22)
    26.67 (4.29 to 49.05)
    29.41 (14.10 to 44.73)
    24.24 (9.62 to 38.86)
        Week 28
    43.33 (30.79 to 55.87)
    46.67 (34.04 to 59.29)
    31.25 (8.54 to 53.96)
    33.33 (9.48 to 57.19)
    32.35 (16.63 to 48.08)
    45.45 (28.47 to 62.44)
        Week 36
    43.33 (30.79 to 55.87)
    43.33 (30.79 to 55.87)
    50.00 (25.50 to 74.50)
    60.00 (35.21 to 84.79)
    29.41 (14.10 to 44.73)
    57.58 (40.71 to 74.44)
        Week 44
    53.33 (40.71 to 65.96)
    50.00 (37.35 to 62.65)
    31.25 (8.54 to 53.96)
    46.67 (21.42 to 71.91)
    32.35 (16.63 to 48.08)
    51.52 (34.46 to 68.57)
        Week 52
    46.67 (34.04 to 59.29)
    48.33 (35.69 to 60.98)
    31.25 (8.54 to 53.96)
    40.00 (15.21 to 64.79)
    41.18 (24.63 to 57.72)
    45.45 (28.47 to 62.44)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Very Low Disease Activity (VLDA) Response at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving Very Low Disease Activity (VLDA) Response at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    A subject was in VLDA when all the 7 following criteria were met: 1) tender joint count ≤1; 2) swollen joint count ≤1; 3) PASI score ≤1 or BSA ≤3%; 4) subject Arthritis Pain (VAS) ≤15 mm; 5) subject's global arthritis assessment (VAS) ≤20 mm; 6) HAQ-DI score ≤0.5; 7) tender entheseal points (using Leed’s enthesitis Index) ≤1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4
    0.82 (0.00 to 3.08)
    0.82 (0.00 to 3.08)
    2.94 (0.00 to 10.97)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 8
    1.67 (0.00 to 4.91)
    1.67 (0.00 to 4.91)
    2.94 (0.00 to 10.97)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 12
    0.82 (0.00 to 3.08)
    3.33 (0.00 to 7.88)
    2.94 (0.00 to 10.97)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 16
    3.39 (0.00 to 8.01)
    5.00 (0.00 to 10.51)
    6.25 (0.00 to 18.11)
    3.13 (0.00 to 11.65)
    1.43 (0.00 to 5.36)
    1.47 (0.00 to 5.52)
        Week 20
    6.67 (0.35 to 12.98)
    11.67 (3.54 to 19.79)
    12.50 (0.00 to 28.70)
    13.33 (0.00 to 30.54)
    2.94 (0.00 to 8.62)
    1.47 (0.00 to 5.52)
        Week 28
    10.00 (2.41 to 17.59)
    10.00 (2.41 to 17.59)
    12.50 (0.00 to 28.70)
    6.67 (0.00 to 19.29)
    8.82 (0.00 to 18.36)
    6.06 (0.00 to 14.20)
        Week 36
    15.00 (5.97 to 24.03)
    15.00 (5.97 to 24.03)
    12.50 (0.00 to 28.70)
    6.67 (0.00 to 19.29)
    5.88 (0.00 to 13.79)
    12.12 (0.99 to 23.26)
        Week 44
    15.00 (5.97 to 24.03)
    16.67 (7.24 to 26.10)
    18.75 (0.00 to 37.87)
    20.00 (0.00 to 40.24)
    14.71 (2.80 to 26.61)
    15.15 (2.92 to 27.38)
        Week 52
    20.00 (9.88 to 30.12)
    16.67 (7.24 to 26.10)
    25.00 (3.78 to 46.22)
    20.00 (0.00 to 40.24)
    11.76 (0.93 to 22.59)
    18.18 (5.02 to 31.34)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    DAREA/DAPSA is a composite instrument to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count + swollen joint count (using SJC66/ TJC68 assessments), patient’s global assessment of Arthritis (PtGA in cm), patient’s assessment of Arthritis Pain (PAIN in cm) and CRP (in mg/dL). Since DAREA reflects domains found important in PsA, it has been proposed to serve as a Disease Activity Index for Psoriatic Arthritis (DAPSA). DAREA/DAPSA is calculated at every study visit during the treatment period except Week 2 visit as follows: DAREA/DAPSA= SJC66 + TJC68 + PtGA + PAIN + CRP. The Baseline is defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment with baseline DAREA/DAPSA.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 4
    -14.05 ( 11.826 )
    -13.99 ( 10.166 )
    -14.15 ( 14.294 )
    -9.81 ( 13.841 )
    -7.11 ( 8.738 )
    -9.08 ( 12.074 )
        Week 8
    -20.36 ( 11.211 )
    -17.55 ( 11.664 )
    -19.19 ( 11.720 )
    -14.33 ( 15.143 )
    -12.46 ( 12.905 )
    -10.98 ( 15.222 )
        Week 12
    -21.93 ( 12.582 )
    -20.91 ( 11.985 )
    -24.91 ( 15.556 )
    -17.77 ( 18.471 )
    -14.68 ( 12.943 )
    -13.04 ( 15.072 )
        Week 16
    -25.15 ( 12.582 )
    -23.55 ( 12.040 )
    -26.65 ( 16.982 )
    -25.89 ( 18.513 )
    -15.83 ( 12.918 )
    -14.45 ( 15.150 )
        Week 20
    -26.75 ( 13.625 )
    -25.24 ( 12.152 )
    -30.63 ( 17.150 )
    -27.01 ( 22.334 )
    -23.53 ( 13.606 )
    -23.63 ( 13.640 )
        Week 28
    -27.13 ( 12.807 )
    -25.38 ( 13.129 )
    -32.63 ( 18.437 )
    -31.41 ( 22.145 )
    -23.54 ( 12.375 )
    -27.55 ( 14.831 )
        Week 36
    -27.21 ( 14.456 )
    -25.84 ( 13.170 )
    -34.98 ( 19.857 )
    -31.53 ( 24.046 )
    -25.57 ( 11.445 )
    -28.22 ( 15.793 )
        Week 44
    -28.39 ( 14.445 )
    -27.54 ( 12.744 )
    -36.61 ( 14.597 )
    -30.22 ( 27.532 )
    -26.43 ( 10.880 )
    -29.59 ( 15.962 )
        Week 52
    -28.56 ( 15.578 )
    -27.40 ( 13.429 )
    -37.81 ( 14.251 )
    -30.32 ( 22.795 )
    -26.45 ( 11.114 )
    -28.95 ( 17.706 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving the Psoriatic Arthritis Response Criteria (PsARC) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Percentage of Subjects Achieving the Psoriatic Arthritis Response Criteria (PsARC) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    The PsARC consists of 4 measurements: Tender joint count (68) - TJC; Swollen joint count (66) - SJC; Physician’s Global Assessment of Arthritis (visual analog scale, VAS); Patient’s Global Assessment of Arthritis (VAS). Specifically, the PsARC response was defined as improvement in 2 of the following 4 criteria, one of which must be joint pain or swelling, without worsening in any measure: (1) ≥20% improvement in Physician’s Global Assessment of Arthritis (VAS); (2) ≥20% improvement in Patient’s Global Assessment of Arthritis (VAS); (3) ≥30% improvement in tender joint count (68); and (4) ≥30% improvement in swollen joint count (66). All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Percentage of subjects
    number (confidence interval 95%)
        Week 4
    50.00 (37.35 to 62.65)
    55.00 (42.41 to 67.59)
    50.00 (25.50 to 74.50)
    40.00 (15.21 to 64.79)
    26.47 (11.64 to 41.30)
    21.21 (7.26 to 35.16)
        Week 8
    66.67 (54.74 to 78.59)
    60.00 (47.60 to 72.40)
    56.25 (31.94 to 80.56)
    40.00 (15.21 to 64.79)
    38.24 (21.90 to 54.57)
    45.45 (28.47 to 62.44)
        Week 12
    66.67 (54.74 to 78.59)
    75.00 (64.04 to 85.96)
    62.50 (38.78 to 86.22)
    60.00 (35.21 to 84.79)
    52.94 (36.16 to 69.72)
    45.45 (28.47 to 62.44)
        Week 16
    83.05 (73.48 to 92.62)
    75.00 (64.04 to 85.96)
    62.50 (38.78 to 86.22)
    66.67 (42.81 to 90.52)
    50.00 (33.19 to 66.81)
    48.48 (31.43 to 65.54)
        Week 20
    78.33 (67.91 to 88.76)
    81.67 (71.88 to 91.46)
    56.25 (31.94 to 80.56)
    60.00 (35.21 to 84.79)
    70.59 (55.27 to 85.90)
    72.73 (57.53 to 87.92)
        Week 28
    81.67 (71.88 to 91.46)
    80.00 (69.88 to 90.12)
    68.75 (46.04 to 91.46)
    73.33 (50.95 to 95.71)
    73.53 (58.70 to 88.36)
    75.76 (61.14 to 90.38)
        Week 36
    66.67 (54.74 to 78.59)
    75.00 (64.04 to 85.96)
    68.75 (46.04 to 91.46)
    80.00 (59.76 to 100.00)
    67.65 (51.92 to 83.37)
    84.85 (72.62 to 97.08)
        Week 44
    66.67 (54.74 to 78.59)
    78.33 (67.91 to 88.76)
    56.25 (31.94 to 80.56)
    73.33 (50.95 to 95.71)
    58.82 (42.28 to 75.37)
    75.76 (61.14 to 90.38)
        Week 52
    58.33 (45.86 to 70.81)
    70.00 (58.40 to 81.60)
    56.25 (31.94 to 80.56)
    66.67 (42.81 to 90.52)
    64.71 (48.64 to 80.77)
    66.67 (50.58 to 82.75)
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

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    End point title
    		 Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at All Treatment Timepoints Except Week 2: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point description
    PASDAS is a composite psoriatic arthritis disease activity score that includes the following components: patient’s global joint and skin assessment (visual analog scale in mm), physician’s global psoriatic arthritis assessment (visual analog scale in mm), swollen (66 joints) and tender joint counts (68 joints), Leeds Enthesitis Index score, tender dactylitic digit score, physical component summary score (PCS) of Short Form 36 Health Survey and C-reactive protein (mg/L). Any missing component would result in PASDAS as missing. A higher PASDAS score indicates a higher disease activity. The baseline was defined as the measurements in Day 1. All subjects who received at least 1 dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Week 4
    -1.22 ( 1.119 )
    -1.31 ( 1.090 )
    -0.94 ( 0.957 )
    -0.65 ( 0.653 )
    -0.56 ( 0.655 )
    -0.54 ( 0.897 )
        Week 8
    -1.79 ( 1.295 )
    -1.65 ( 1.262 )
    -1.37 ( 1.127 )
    -1.14 ( 1.122 )
    -1.02 ( 0.988 )
    -0.67 ( 1.045 )
        Week 12
    -2.10 ( 1.380 )
    -1.93 ( 1.278 )
    -1.67 ( 0.996 )
    -1.61 ( 1.106 )
    -1.04 ( 1.101 )
    -0.80 ( 1.158 )
        Week 16
    -2.31 ( 1.302 )
    -2.20 ( 1.354 )
    -1.87 ( 1.024 )
    -2.18 ( 1.286 )
    -1.08 ( 1.127 )
    -0.90 ( 1.193 )
        Week 20
    -2.48 ( 1.338 )
    -2.48 ( 1.474 )
    -2.49 ( 1.199 )
    -2.18 ( 1.441 )
    -2.37 ( 1.202 )
    -2.10 ( 1.367 )
        Week 28
    -2.62 ( 1.354 )
    -2.60 ( 1.642 )
    -2.90 ( 1.279 )
    -3.18 ( 1.484 )
    -2.48 ( 1.181 )
    -2.81 ( 1.302 )
        Week 36
    -2.73 ( 1.509 )
    -2.59 ( 1.644 )
    -3.08 ( 1.539 )
    -2.97 ( 1.550 )
    -2.69 ( 1.043 )
    -2.96 ( 1.425 )
        Week 44
    -2.95 ( 1.421 )
    -2.85 ( 1.637 )
    -3.25 ( 0.819 )
    -3.23 ( 1.833 )
    -2.73 ( 1.157 )
    -3.23 ( 1.508 )
        Week 52
    -3.03 ( 1.487 )
    -2.98 ( 1.568 )
    -3.36 ( 0.826 )
    -3.14 ( 1.461 )
    -2.84 ( 1.399 )
    -3.07 ( 1.775 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)
    End point description
    An AE is any untoward medical occurrence in a study subjects administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the subject or may require intervention to prevent one of the other AE outcomes. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were treatment-emergent AEs. All participants who received at least one dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (Day 1) through Week 56
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Subjects
        Subjects with AEs
    46
    45
    10
    10
    24
    25
        Subjects with SAEs
    1
    8
    0
    0
    1
    2
        Subjects with severe AEs
    1
    6
    0
    0
    1
    2
        Subjects discontinued from study due to AEs
    0
    1
    0
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) from Baseline (Day 1) Through Week 56 (Treatment-Related)

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    End point title
    		 Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) from Baseline (Day 1) Through Week 56 (Treatment-Related)
    End point description
    An AE is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event that may jeopardize the subject or may require intervention to prevent one of the other AE outcomes. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. Treatment-related AEs were determined by the investigators. All participants who received at least one dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (Day 1) through Week 56
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Subjects
        Subjects with AEs
    17
    15
    6
    2
    11
    10
        Subjects with SAEs
    0
    1
    0
    0
    1
    1
        Subjects with severe AEs
    0
    1
    0
    0
    1
    1
        Subjects discontinued from study due to AEs
    0
    1
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects who Discontinued From the Study Due to Treatment-Emergent AEs From Baseline (Day 1) Through Week 56

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    End point title
    		 Number of Subjects who Discontinued From the Study Due to Treatment-Emergent AEs From Baseline (Day 1) Through Week 56
    End point description
    An AE is any untoward medical occurrence in a study subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of the study medication. Analysis population is all participants who received at least one dose of the randomized study treatment.
    End point type
    Secondary
    End point timeframe
    From baseline (Day 1) through Week 56
    End point values
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Number of subjects analysed
    60
    60
    16
    15
    34
    33
    Units: Subjects
        Otitis media acute
    0
    1
    0
    0
    0
    0
        Upper respiratory tract infection
    0
    0
    0
    0
    0
    1
        Psoriasis
    0
    0
    0
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time the subject took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 56 Weeks)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    PF-06700841 60 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-06700841 30 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 60 mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    PF-06700841 10 mg QD -> PF-06700841 30 mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    Placebo -> PF-06700841 60 mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Reporting group title
    Placebo -> PF-06700841 30 mg QD
    Reporting group description
    		 Treatment Group Description TBD

    Serious adverse events
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    8 / 60 (13.33%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PF-06700841 60 mg QD -> PF-06700841 60 mg QD PF-06700841 30 mg QD -> PF-06700841 30 mg QD PF-06700841 10 mg QD -> PF-06700841 60 mg QD PF-06700841 10 mg QD -> PF-06700841 30 mg QD Placebo -> PF-06700841 60 mg QD Placebo -> PF-06700841 30 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 60 (61.67%)
    34 / 60 (56.67%)
    10 / 16 (62.50%)
    10 / 15 (66.67%)
    18 / 34 (52.94%)
    20 / 33 (60.61%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 60 (8.33%)
    7 / 60 (11.67%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    7
    10
    3
    1
    3
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 60 (6.67%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    4
    5
    1
    0
    2
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    Transaminases increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 60 (5.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    2 / 34 (5.88%)
    1 / 33 (3.03%)
         occurrences all number
    5
    4
    0
    1
    3
    1
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 60 (8.33%)
    2 / 60 (3.33%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
         occurrences all number
    6
    2
    1
    0
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 60 (8.33%)
    4 / 60 (6.67%)
    2 / 16 (12.50%)
    1 / 15 (6.67%)
    1 / 34 (2.94%)
    3 / 33 (9.09%)
         occurrences all number
    6
    6
    3
    1
    1
    3
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 60 (3.33%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
         occurrences all number
    2
    2
    0
    0
    3
    1
    Leukopenia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    3
    0
    0
    1
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 60 (1.67%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    3
    1
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    4 / 60 (6.67%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    6
    0
    0
    1
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    2
    0
    1
    1
    0
    1
    Nausea
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
         occurrences all number
    4
    1
    0
    0
    3
    1
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Skin mass
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Acne
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    1
    2
    1
    0
    1
    0
    Psoriasis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    1
    0
    1
    0
    1
    2
    Rash
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    1
    1
    0
    0
    2
    2
    Spinal pain
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    1
    1
    1
    1
    0
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 60 (1.67%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 60 (3.33%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    4
    1
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 60 (6.67%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    7
    5
    1
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    4 / 60 (6.67%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    2 / 15 (13.33%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
         occurrences all number
    4
    0
    1
    2
    1
    1
    COVID-19
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 60 (3.33%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    1
    2
    0
    1
    1
    2
    Cystitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 60 (1.67%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    8 / 60 (13.33%)
    5 / 60 (8.33%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
    1 / 34 (2.94%)
    4 / 33 (12.12%)
         occurrences all number
    10
    5
    0
    2
    1
    4
    Pharyngitis
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 60 (3.33%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    4
    2
    0
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 60 (1.67%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    2
    1
    1
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 60 (11.67%)
    5 / 60 (8.33%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    2 / 34 (5.88%)
    3 / 33 (9.09%)
         occurrences all number
    8
    6
    0
    0
    4
    4
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2019
    Section 4.4.1 Contraception was updated to include an instruction that male subjects should refrain from sperm donation during the study and for a period of at least 90 days after completion of active treatment.
    22 Oct 2019
    Section 1.2.6 Summary of Benefit Risk Assessment was amended to reflect some of the updates made in Section 7 of the current Investigator’s Brochure (IB), particularly the addition of QT prolongation as a potential risk and the addition of the pulmonary embolism and the adjudication committee for suspected thrombotic and embolic events. Section 4.4.1. Contraception. Sexually active male subjects with female partners of child bearing potential are no longer required to use a condom to prevent potential transfer to and exposure of partner(s) to drug through ejaculate. Appendix 6. Discontinuation Criteria. Additional discontinuation criterion added to clarify that study drug will be discontinued and the subject withdrawn from the study treatment in the event of any of the following: serious thromboembolic events, including venous thrombosis (including but not limited to deep vein thrombosis [DVT], pulmonary embolism [PE]), arterial thrombosis, and cerebrovascular events (thromboembolic stroke, transient ischemic attack [TIA], etc.) requiring hospitalization for treatment, or meeting other criteria that require the thromboembolic event to be classified as a serious adverse event (SAE). Appendix 6. Discontinuation Criteria. Additional discontinuation criteria added to clarify that study drug will be discontinued and the subject withdrawn from the study treatment in the event of any of the following: Two sequential AST or ALT elevation >=3 times the upper limit of normal with at least one total bilirubin value >=2 times the upper limit of normal; Two sequential AST or ALT elevation >=3 times the upper limit of normal accompanied by signs or symptoms consistent with hepatic injury; Two sequential AST or ALT elevation >=5 times the upper limit of normal, regardless of total bilirubin or accompanying signs or symptoms.

    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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