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    Clinical Trial Results:
    A 12 Week Randomized, Double-Blind, Double-Dummy, Parallel Group, Active and Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety Profile of PF-06650833 in Subjects With Active Rheumatoid Arthritis With an Inadequate Response to Methotrexate

    Summary
    EudraCT number
    2016-002337-30
    Trial protocol
    BG   DE   HU   CZ   SK   ES   HR  
    Global end of trial date
    15 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Aug 2019
    First version publication date
    21 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B7921005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02996500
    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 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 18007181021, 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
    15 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of PF-06650833 at 12 weeks, in subjects with moderately severely active rheumatoid arthritis who had had an inadequate response to methotrexate.
    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 Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Romania: 7
    Country: Number of subjects enrolled
    Russian Federation: 23
    Country: Number of subjects enrolled
    Serbia: 33
    Country: Number of subjects enrolled
    Slovakia: 12
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 21
    Country: Number of subjects enrolled
    Bulgaria: 15
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    Georgia: 33
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Ukraine: 19
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    269
    EEA total number of subjects
    103
    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)
    232
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 669 subjects were screened, 269 subjects were assigned to and treated with: placebo (39 subjects), PF-06650833 (187 subjects), or tofacitinib (43 subjects). Of the 269 subjects, 237 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four matching PF-06650833 MR placebo tablets were administrated QD and 1 matching tofacitinib placebo tablet was administrated BID in 12 weeks treatment period.

    Arm title
    Tofa 10 mg
    Arm description
    Subjects received 4 matching PF-06650833 MR placebo tablets QD and 1 tofacitinib 5 mg tablet BID in 12 weeks treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four matching PF-06650833 MR placebo tablets were administrated QD in 12 weeks treatment period.

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tofacitinib 5 mg tablet was administrated BID in 12 weeks treatment period.

    Arm title
    PF-06650833 20 mg
    Arm description
    Subjects received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three matching PF-06650833 MR placebo tablets were administrated QD and 1 matching tofacitinib placebo tablet was administrated BID in 12 weeks treatment period.

    Investigational medicinal product name
    PF-06650833
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One MR tablet of PF-06650833 20 mg was administrated QD in 12 weeks treatment period.

    Arm title
    PF-06650833 60 mg
    Arm description
    Subjects received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One matching PF-06650833 MR placebo tablets was administrated QD and 1 matching tofacitinib placebo tablet was administrated BID in 12 weeks treatment period.

    Investigational medicinal product name
    PF-06650833
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three MR tablets of PF-06650833 20 mg were administrated QD in 12 weeks treatment period.

    Arm title
    PF-06650833 200 mg
    Arm description
    Subjects received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-06650833
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two MR tablets of PF-06650833 100 mg were administrated QD in 12 weeks treatment period.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two matching PF-06650833 MR placebo tablets were administrated QD and 1 matching tofacitinib placebo tablet was administrated BID in 12 weeks treatment period.

    Arm title
    PF-06650833 400 mg
    Arm description
    Subjects received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One matching tofacitinib placebo tablet was administrated BID in 12 weeks treatment period.

    Investigational medicinal product name
    PF-06650833
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four MR tablets of PF-06650833 100 mg were administrated QD in 12 weeks treatment period.

    Number of subjects in period 1
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Started
    39
    43
    39
    50
    50
    48
    Completed
    31
    42
    29
    46
    45
    44
    Not completed
    8
    1
    10
    4
    5
    4
         Consent withdrawn by subject
    3
    -
    3
    -
    2
    -
         Adverse event, non-fatal
    1
    1
    4
    3
    1
    2
         Progressive Disease
    1
    -
    -
    -
    -
    -
         Non-Compliance With Study Drug
    -
    -
    -
    -
    -
    1
         Unspecified
    2
    -
    2
    -
    -
    -
         Lost to follow-up
    1
    -
    -
    -
    -
    1
         No Longer Meets Eligibility Criteria
    -
    -
    1
    -
    -
    -
         Protocol deviation
    -
    -
    -
    1
    -
    -
         Lack of efficacy
    -
    -
    -
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.

    Reporting group title
    Tofa 10 mg
    Reporting group description
    Subjects received 4 matching PF-06650833 MR placebo tablets QD and 1 tofacitinib 5 mg tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 20 mg
    Reporting group description
    Subjects received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 60 mg
    Reporting group description
    Subjects received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 200 mg
    Reporting group description
    Subjects received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 400 mg
    Reporting group description
    Subjects received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group values
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg Total
    Number of subjects
    39 43 39 50 50 48 269
    Age, Customized
    Units: Subjects
        In utero
    0 0 0 0 0 0 0
        Preterm newborn infants (gestational age <37 wks)
    0 0 0 0 0 0 0
        Newborns(0-27 days)
    0 0 0 0 0 0 0
        Infants and toddlers(28 days - 23 months)
    0 0 0 0 0 0 0
        Children(2-11 years)
    0 0 0 0 0 0 0
        Adolescents(12-17 years)
    0 0 0 0 0 0 0
        Adults(18-64 years)
    33 38 32 44 43 42 232
        Adults(65-84 years)
    6 5 7 6 7 6 37
        Adults(85 years and over)
    0 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    54.9 ± 10.51 52.7 ± 10.02 55.9 ± 9.74 51.0 ± 12.05 53.6 ± 11.47 54.8 ± 8.76 -
    Sex: Female, Male
    Units: Subjects
        Female
    30 31 31 42 39 37 210
        Male
    9 12 8 8 11 11 59
    Race/Ethnicity, Customized
    Units: Subjects
        White
    37 43 37 47 47 43 254
        Black or African American
    0 0 0 0 0 0 0
        Asian
    2 0 1 1 2 2 8
        American Indian or Alaska Native
    0 0 0 1 1 0 2
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0
        Other
    0 0 1 1 0 3 5

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.

    Reporting group title
    Tofa 10 mg
    Reporting group description
    Subjects received 4 matching PF-06650833 MR placebo tablets QD and 1 tofacitinib 5 mg tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 20 mg
    Reporting group description
    Subjects received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 60 mg
    Reporting group description
    Subjects received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 200 mg
    Reporting group description
    Subjects received 2 MR tablets of PF-06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 400 mg
    Reporting group description
    Subjects received 4 MR tablets of PF-06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Primary: Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12

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    End point title
    Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 [1]
    End point description
    The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0–10 cm scale) + Physician’s Global Assessment of Arthritis (PhGA) (0–10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL).
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    34
    30
    45
    44
    45
    Units: units on a scale
    arithmetic mean (confidence interval 95%)
        Week 12
    -13.87 (-17.70 to -10.02)
    -21.71 (-26.14 to -17.20)
    -22.83 (-26.57 to -19.20)
    -24.77 (-28.54 to -21.08)
    -25.16 (-28.85 to -21.39)
    Statistical analysis title
    Statistical Comparison in SDAI at Week 12
    Statistical analysis description
    Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate. The Confidence Interval was Credible Interval in this analysis.
    Comparison groups
    Placebo v PF-06650833 20 mg
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -7.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.73
         upper limit
    -1.97
    Statistical analysis title
    Statistical Comparison in SDAI at Week 12
    Statistical analysis description
    Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate. The Confidence Interval was Credible Interval in this analysis.
    Comparison groups
    Placebo v PF-06650833 60 mg
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -8.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.37
         upper limit
    -3.66
    Statistical analysis title
    Statistical Comparison in SDAI at Week 12
    Statistical analysis description
    Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate. The Confidence Interval was Credible Interval in this analysis.
    Comparison groups
    Placebo v PF-06650833 200 mg
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -10.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.36
         upper limit
    -5.63
    Statistical analysis title
    Statistical Comparison in SDAI at Week 12
    Statistical analysis description
    Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate. The Confidence Interval was Credible Interval in this analysis.
    Comparison groups
    Placebo v PF-06650833 400 mg
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -11.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.62
         upper limit
    -5.92

    Secondary: Change From Baseline in SDAI at Weeks 4 and 8

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    End point title
    Change From Baseline in SDAI at Weeks 4 and 8 [2]
    End point description
    The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0–10 cm scale) + PhGA (0–10 cm scale) + hsCRP (mg/dL).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4 and 8
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [3]
    39 [4]
    50 [5]
    50 [6]
    48 [7]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -10.78 (-15.07 to -6.49)
    -12.39 (-14.68 to -10.10)
    -14.29 (-16.87 to -11.71)
    -13.56 (-17.25 to -9.86)
    -12.30 (-15.46 to -9.14)
        Week 8
    -17.07 (-22.58 to -11.55)
    -16.62 (-20.71 to -12.53)
    -18.85 (-22.03 to -15.67)
    -19.95 (-24.81 to -15.08)
    -21.15 (-25.50 to -16.79)
    Notes
    [3] - Number of Subjects Analyzed at Weeks 4 and 8: 37, 34
    [4] - Number of Subjects Analyzed at Weeks 4 and 8: 37, 34
    [5] - Number of Subjects Analyzed at Weeks 4 and 8: 49, 46
    [6] - Number of Subjects Analyzed at Weeks 4 and 8: 47, 41
    [7] - Number of Subjects Analyzed at Weeks 4 and 8: 47, 45
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at Weeks 4, 8 and 12 [8]
    End point description
    The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0–10 cm scale) + PhGA (0–10 cm scale) + hsCRP (mg/dL). The criterion of SDAI LDAS was SDAI<=11.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [9]
    39 [10]
    50 [11]
    50 [12]
    48 [13]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    8.1 (0.0 to 16.9)
    7.9 (0.0 to 16.5)
    12.2 (3.1 to 21.4)
    10.6 (1.8 to 19.5)
    8.5 (0.5 to 16.5)
        Week 8
    14.7 (2.8 to 26.6)
    20.0 (6.7 to 33.3)
    17.4 (6.4 to 28.3)
    29.3 (15.3 to 43.2)
    33.3 (19.6 to 47.1)
        Week 12
    26.5 (11.6 to 41.3)
    41.9 (24.6 to 59.3)
    28.9 (15.6 to 42.1)
    38.6 (24.2 to 53.0)
    42.2 (27.8 to 56.7)
    Notes
    [9] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [10] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [11] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [12] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [13] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with SDAI Remission (SDAI <=3.3) at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects with SDAI Remission (SDAI <=3.3) at Weeks 4, 8 and 12 [14]
    End point description
    The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0–10 cm scale) + PhGA (0–10 cm scale) + hsCRP (mg/dL). The criterion of SDAI remission was SDAI<=3.3.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [15]
    39 [16]
    50 [17]
    50 [18]
    48 [19]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    0 (0.0 to 0.0)
    2.6 (0.0 to 7.7)
    2.0 (0.0 to 6.0)
    0 (0.0 to 0.0)
    2.1 (0.0 to 6.3)
        Week 8
    0 (0.0 to 0.0)
    8.6 (0.0 to 17.8)
    0 (0.0 to 0.0)
    7.3 (0.0 to 15.3)
    2.2 (0.0 to 6.5)
        Week 12
    2.9 (0.0 to 8.6)
    3.2 (0.0 to 9.4)
    2.2 (0.0 to 6.5)
    6.8 (0.0 to 14.3)
    8.9 (0.6 to 17.2)
    Notes
    [15] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [16] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [17] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [18] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [19] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12

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    End point title
    Percentage of Subjects with Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12 [20]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Higher score indicated more disease activity. The criterion of DAS28-4 LDAS was DAS28<3.2.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [21]
    39 [22]
    50 [23]
    50 [24]
    48 [25]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    2.9 (0.0 to 8.4)
    8.1 (0.0 to 16.9)
    6.4 (0.0 to 13.4)
    8.3 (0.5 to 16.2)
    4.3 (0.0 to 10.0)
        Week 8
    8.6 (0.0 to 17.8)
    17.1 (4.7 to 29.6)
    13.6 (3.5 to 23.8)
    13.3 (3.4 to 23.3)
    12.8 (3.2 to 22.3)
        Week 12
    17.6 (4.8 to 30.5)
    20.0 (5.7 to 34.3)
    24.4 (11.9 to 37.0)
    22.2 (10.1 to 34.4)
    17.8 (6.6 to 28.9)
    Notes
    [21] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 35, 34, 34.
    [22] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 30.
    [23] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 44, 45.
    [24] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 45, 45.
    [25] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 47, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-3 (ESR) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12

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    End point title
    Percentage of Subjects With DAS28-3 (ESR) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12 [26]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mg/L]*1.08 + 0.16. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [27]
    39 [28]
    50 [29]
    50 [30]
    48 [31]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    5.7 (0.0 to 13.4)
    8.1 (0.0 to 16.9)
    10.6 (1.8 to 19.5)
    8.3 (0.5 to 16.2)
    4.3 (0.0 to 10.0)
        Week 8
    8.6 (0.0 to 17.8)
    20.0 (6.7 to 33.3)
    15.9 (5.1 to 26.7)
    8.9 (0.6 to 17.2)
    14.9 (4.7 to 25.1)
        Week 12
    20.6 (7.0 to 34.2)
    20.0 (5.7 to 34.3)
    22.2 (10.1 to 34.4)
    22.2 (10.1 to 34.4)
    15.6 (5.0 to 26.1)
    Notes
    [27] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 35, 35, 34.
    [28] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 30.
    [29] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 44, 45.
    [30] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 45, 45.
    [31] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 47, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12

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    End point title
    Percentage of Subjects with Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12 [32]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Higher score indicated more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). The criterion of DAS28-4 LDAS was DAS28<3.2.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [33]
    39 [34]
    50 [35]
    50 [36]
    48 [37]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    8.1 (0.0 to 16.9)
    13.2 (2.4 to 23.9)
    16.3 (6.0 to 26.7)
    12.8 (3.2 to 22.3)
    8.5 (0.5 to 16.5)
        Week 8
    11.8 (0.9 to 22.6)
    20.0 (6.7 to 33.3)
    19.6 (8.1 to 31.0)
    26.8 (13.3 to 40.4)
    33.3 (19.6 to 47.1)
        Week 12
    20.6 (7.0 to 34.2)
    38.7 (21.6 to 55.9)
    35.6 (21.6 to 49.5)
    40.9 (26.4 to 55.4)
    42.2 (27.8 to 56.7)
    Notes
    [33] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [34] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [35] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [36] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [37] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-3 (CRP) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12

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    End point title
    Percentage of Subjects With DAS28-3 (CRP) LDAS (DAS28 <3.2) at Weeks 4, 8, and 12 [38]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Higher score indicated more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). The criterion of DAS28-3 LDAS was DAS28<3.2.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [39]
    39 [40]
    50 [41]
    50 [42]
    48 [43]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    8.1 (0.0 to 16.9)
    10.5 (0.8 to 20.3)
    16.3 (6.0 to 26.7)
    17.0 (6.3 to 27.8)
    10.6 (1.8 to 19.5)
        Week 8
    20.6 (7.0 to 34.2)
    22.9 (8.9 to 36.8)
    19.6 (8.1 to 31.0)
    34.1 (19.6 to 48.7)
    37.8 (23.6 to 51.9)
        Week 12
    23.5 (9.3 to 37.8)
    41.9 (24.6 to 59.3)
    40.0 (25.7 to 54.3)
    47.7 (33.0 to 62.5)
    42.2 (27.8 to 56.7)
    Notes
    [39] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [40] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [41] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [42] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [43] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-4 (ESR) Remission (DAS28 <2.6) at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects With DAS28-4 (ESR) Remission (DAS28 <2.6) at Weeks 4, 8 and 12 [44]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mg/L] + 0.014 (PtGA [mm]). Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [45]
    39 [46]
    50 [47]
    50 [48]
    48 [49]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    0 (0.0 to 0.0)
    5.4 (0.0 to 12.7)
    2.1 (0.0 to 6.3)
    8.3 (0.5 to 16.2)
    2.1 (0.0 to 6.3)
        Week 8
    5.7 (0.0 to 13.4)
    11.4 (0.9 to 22.0)
    9.1 (0.6 to 17.6)
    6.7 (0.0 to 14.0)
    10.6 (1.8 to 19.5)
        Week 12
    5.9 (0.0 to 13.8)
    16.7 (3.3 to 30.0)
    13.3 (3.4 to 23.3)
    8.9 (0.6 to 17.2)
    11.1 (1.9 to 20.3)
    Notes
    [45] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 35, 35, 34.
    [46] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 30.
    [47] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 44, 45.
    [48] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 45, 45.
    [49] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 47, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-3 (ESR) Remission (DAS28 <2.6) at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects With DAS28-3 (ESR) Remission (DAS28 <2.6) at Weeks 4, 8 and 12 [50]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mg/L]*1.08 + 0.16. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [51]
    39 [52]
    50 [53]
    50 [54]
    48 [55]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    0 (0.0 to 0.0)
    2.7 (0.0 to 7.9)
    2.1 (0.0 to 6.3)
    6.3 (0.0 to 13.1)
    2.1 (0.0 to 6.3)
        Week 8
    2.9 (0.0 to 8.4)
    8.6 (0.0 to 17.8)
    9.1 (0.6 to 17.6)
    6.7 (0.0 to 14.0)
    8.5 (0.5 to 16.5)
        Week 12
    8.8 (0.0 to 18.4)
    10.0 (0.0 to 20.7)
    13.3 (3.4 to 23.3)
    11.1 (1.9 to 20.3)
    8.9 (0.6 to 17.2)
    Notes
    [51] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 35, 35, 34.
    [52] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 30.
    [53] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 44, 45.
    [54] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 45, 45.
    [55] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 47, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-4 (CRP) Remission (DAS28 <2.6) at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects With DAS28-4 (CRP) Remission (DAS28 <2.6) at Weeks 4, 8 and 12 [56]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Higher score indicated more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). The criterion of DAS28-4 remission was DAS28<2.6.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [57]
    39 [58]
    50 [59]
    50 [60]
    48 [61]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    2.7 (0.0 to 7.9)
    5.3 (0.0 to 12.4)
    8.2 (0.5 to 15.8)
    10.6 (1.8 to 19.5)
    6.4 (0.0 to 13.4)
        Week 8
    8.8 (0.0 to 18.4)
    17.1 (4.7 to 29.6)
    10.9 (1.9 to 19.9)
    22.0 (9.3 to 34.6)
    13.3 (3.4 to 23.3)
        Week 12
    14.7 (2.8 to 26.6)
    22.6 (7.9 to 37.3)
    17.8 (6.6 to 28.9)
    25.0 (12.2 to 37.8)
    24.4 (11.9 to 37.0)
    Notes
    [57] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [58] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [59] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [60] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [61] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With DAS28-3 (CRP) Remission (DAS28 <2.6) at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects With DAS28-3 (CRP) Remission (DAS28 <2.6) at Weeks 4, 8 and 12 [62]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Higher score indicated more disease activity. The possible lowest score is 1.15. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level. The criterion of DAS28-3 remission was DAS28<2.6.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [63]
    39 [64]
    50 [65]
    50 [66]
    48 [67]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    5.4 (0.0 to 12.7)
    5.3 (0.0 to 12.4)
    10.2 (1.7 to 18.7)
    8.5 (0.5 to 16.5)
    4.3 (0.0 to 10.0)
        Week 8
    8.8 (0.0 to 18.4)
    14.3 (2.7 to 25.9)
    10.9 (1.9 to 19.9)
    22.0 (9.3 to 34.6)
    13.3 (3.4 to 23.3)
        Week 12
    11.8 (0.9 to 22.6)
    25.8 (10.4 to 41.2)
    22.2 (10.1 to 34.4)
    22.7 (10.3 to 35.1)
    22.2 (10.1 to 34.4)
    Notes
    [63] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [64] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [65] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [66] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [67] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28-4 (ESR) at Weeks 4, 8 and 12

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    End point title
    Change From Baseline in DAS28-4 (ESR) at Weeks 4, 8 and 12 [68]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Higher score indicated more disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [69]
    39 [70]
    50 [71]
    50 [72]
    48 [73]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -0.80 (-1.13 to -0.47)
    -1.15 (-1.47 to -0.82)
    -1.35 (-1.64 to -1.07)
    -1.14 (-1.42 to -0.86)
    -1.13 (-1.42 to -0.84)
        Week 8
    -1.38 (-1.80 to -0.97)
    -1.59 (-2.01 to -1.17)
    -1.92 (-2.29 to -1.56)
    -1.77 (-2.14 to -1.41)
    -2.01 (-2.37 to -1.64)
        Week 12
    -1.55 (-1.97 to -1.13)
    -1.85 (-2.28 to -1.41)
    -2.37 (-2.74 to -2.01)
    -2.23 (-2.60 to -1.86)
    -2.36 (-2.73 to -1.99)
    Notes
    [69] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 35, 35, 34.
    [70] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 30.
    [71] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 44, 45.
    [72] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 45, 45.
    [73] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 47, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28-3 (ESR) at Weeks 4, 8 and 12

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    End point title
    Change From Baseline in DAS28-3 (ESR) at Weeks 4, 8 and 12 [74]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08 + 0.16. Higher score indicated more disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [75]
    39 [76]
    50 [77]
    50 [78]
    48 [79]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -0.69 (-1.01 to -0.38)
    -1.08 (-1.39 to -0.77)
    -1.25 (-1.52 to -0.97)
    -1.08 (-1.35 to -0.80)
    -1.02 (-1.29 to -0.74)
        Week 8
    -1.14 (-1.54 to -0.75)
    -1.52 (-1.92 to -1.12)
    -1.80 (-2.15 to -1.45)
    -1.62 (-1.97 to -1.27)
    -1.79 (-2.14 to -1.44)
        Week 12
    -1.31 (-1.71 to -0.92)
    -1.69 (-2.09 to -1.28)
    -2.26 (-2.60 to -1.91)
    -2.05 (-2.40 to -1.71)
    -2.04 (-2.38 to -1.69)
    Notes
    [75] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 35, 35, 34.
    [76] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 30.
    [77] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 44, 45.
    [78] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 45, 45.
    [79] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 47, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28-4 (CRP) at Weeks 4, 8 and 12

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    End point title
    Change From Baseline in DAS28-4 (CRP) at Weeks 4, 8 and 12 [80]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PGtA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGtA [mm]) + 0.96. Higher score indicated more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [81]
    39 [82]
    50 [83]
    50 [84]
    48 [85]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -0.72 (-1.02 to -0.42)
    -0.99 (-1.29 to -0.69)
    -1.21 (-1.47 to -0.94)
    -1.08 (-1.34 to -0.81)
    -0.99 (-1.25 to -0.72)
        Week 8
    -1.20 (-1.58 to -0.83)
    -1.31 (-1.68 to -0.94)
    -1.59 (-1.92 to -1.27)
    -1.65 (-1.98 to -1.32)
    -1.73 (-2.06 to -1.40)
        Week 12
    -1.38 (-1.78 to -0.97)
    -1.67 (-2.08 to -1.26)
    -1.94 (-2.29 to -1.59)
    -2.00 (-2.36 to -1.65)
    -2.12 (-2.47 to -1.77)
    Notes
    [81] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [82] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [83] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [84] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [85] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS28-3 (CRP) at Weeks 4, 8 and 12

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    End point title
    Change From Baseline in DAS28-3 (CRP) at Weeks 4, 8 and 12 [86]
    End point description
    The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Higher score indicated more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [87]
    39 [88]
    50 [89]
    50 [90]
    48 [91]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -0.61 (-0.90 to -0.32)
    -0.93 (-1.22 to -0.64)
    -1.09 (-1.35 to -0.84)
    -1.01 (-1.27 to -0.76)
    -0.88 (-1.14 to -0.62)
        Week 8
    -0.97 (-1.32 to -0.61)
    -1.24 (-1.60 to -0.89)
    -1.46 (-1.76 to -1.15)
    -1.52 (-1.83 to -1.20)
    -1.52 (-1.83 to -1.21)
        Week 12
    -1.14 (-1.52 to -0.77)
    -1.53 (-1.91 to -1.15)
    -1.82 (-2.14 to -1.50)
    -1.83 (-2.51 to -1.50)
    -1.82 (-2.51 to -1.50)
    Notes
    [87] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 34, 34.
    [88] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 38, 35, 31.
    [89] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 49, 46, 45.
    [90] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 41, 44.
    [91] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 47, 45, 45.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Weeks 4, 8 and 12 [92]
    End point description
    ACR20 was calculated as a 20% improvement in TJC and SJC and 20% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhGA, pain, disability, and an acute-phase reactant which for this study was CRP or ESR.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [93]
    39 [94]
    50 [95]
    50 [96]
    48 [97]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    30.8 (16.3 to 45.3)
    35.9 (20.8 to 51.0)
    42.0 (28.3 to 55.7)
    40.0 (26.4 to 53.6)
    37.5 (23.8 to 51.2)
        Week 8
    46.2 (30.5 to 61.8)
    51.3 (35.6 to 67.0)
    58.0 (44.3 to 71.7)
    52.0 (38.2 to 65.8)
    64.6 (51.1 to 78.1)
        Week 12
    51.3 (35.6 to 67.0)
    48.7 (33.0 to 64.4)
    66.0 (52.9 to 79.1)
    62.0 (48.5 to 75.5)
    70.8 (58.0 to 83.7)
    Notes
    [93] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 39, 39, 39.
    [94] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 39, 39, 39.
    [95] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 50, 50, 50.
    [96] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 50, 50, 50.
    [97] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 48, 48.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Weeks 4, 8 and 12 [98]
    End point description
    ACR50 was calculated as a 50% improvement in TJC and SJC and 50% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhGA, pain, disability, and an acute-phase reactant which for this study was CRP or ESR.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [99]
    39 [100]
    50 [101]
    50 [102]
    48 [103]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    2.6 (0.0 to 7.5)
    10.3 (0.7 to 19.8)
    6.0 (0.0 to 12.6)
    6.0 (0.0 to 12.6)
    8.3 (0.5 to 16.2)
        Week 8
    12.8 (2.3 to 23.3)
    23.1 (9.9 to 36.3)
    14.0 (4.4 to 23.6)
    22.0 (10.5 to 33.5)
    35.4 (21.9 to 48.9)
        Week 12
    20.5 (7.8 to 33.2)
    25.6 (11.9 to 39.3)
    22.0 (10.5 to 33.5)
    40.0 (26.4 to 53.6)
    43.8 (29.7 to 57.8)
    Notes
    [99] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 39, 39, 39.
    [100] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 39, 39, 39.
    [101] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 50, 50, 50.
    [102] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 50, 50, 50.
    [103] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 48, 48.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Weeks 4, 8 and 12

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    End point title
    Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Weeks 4, 8 and 12 [104]
    End point description
    ACR70 was calculated as a 70% improvement in TJC and SJC and 70% improvement in 3 of the 5 remaining ACR-core set measures: PtGA and PhGA, pain, disability, and an acute-phase reactant which for this study was CRP or ESR.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    Notes
    [104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [105]
    39 [106]
    50 [107]
    50 [108]
    48 [109]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 4
    0.0 (0.0 to 0.0)
    5.1 (0.0 to 12.1)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    4.2 (0.0 to 9.8)
        Week 8
    2.6 (0.0 to 7.5)
    10.3 (0.7 to 19.8)
    0.0 (0.0 to 0.0)
    10.0 (1.7 to 18.3)
    6.3 (0.0 to 13.1)
        Week 12
    5.1 (0.0 to 12.1)
    7.7 (0.0 to 16.1)
    6.0 (0.0 to 12.6)
    14.0 (4.4 to 23.6)
    10.4 (1.8 to 19.1)
    Notes
    [105] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 39, 39, 39.
    [106] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 39, 39, 39.
    [107] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 50, 50, 50.
    [108] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 50, 50, 50.
    [109] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 48, 48, 48.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Tender/Painful and Swollen Joint Counts at Weeks 4, 8 and 12

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    End point title
    Change From Baseline in the Tender/Painful and Swollen Joint Counts at Weeks 4, 8 and 12 [110]
    End point description
    The TJC (28) included the following joints: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees. This count was calculated from the TJC (68) assessed. The SJC (28) included the same joints as TJC (28), and was calculated from the SJC 66 assessed for swelling.Sixty eight (68) joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. The 68 joints assessed were: temporomandibular, sternoclavicular, acromioclavicular; shoulder, elbow, wrist, metacarpophalangeals, thumb interphalangeal, proximal interphalangeals, and distal interphalangeals; lower extremity including hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined. Sixty-six (66) joints were assessed for swelling, the same as those listed for TJC, excluding the right and left hip joints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [111]
    39 [112]
    50 [113]
    50 [114]
    48 [115]
    Units: joints
    arithmetic mean (standard deviation)
        SJC (28) at Week 4
    -4.4 ± 6.01
    -4.8 ± 3.64
    -4.4 ± 3.76
    -5.0 ± 4.87
    -3.8 ± 4.25
        SJC (28) at Week 8
    -6.1 ± 6.75
    -6.0 ± 4.70
    -6.1 ± 4.80
    -7.0 ± 5.31
    -6.8 ± 5.75
        SJC (28) at Week 12
    -6.3 ± 5.61
    -6.8 ± 5.21
    -6.6 ± 5.38
    -8.1 ± 5.73
    -8.2 ± 6.01
        TJC (28) at Week 4
    -4.0 ± 5.99
    -4.9 ± 5.01
    -5.5 ± 5.12
    -4.8 ± 6.14
    -4.4 ± 5.36
        TJC (28) at Week 8
    -5.9 ± 7.16
    -6.9 ± 6.18
    -7.0 ± 5.83
    -7.5 ± 7.13
    -7.8 ± 6.72
        TJC (28) at Week 12
    -7.5 ± 6.39
    -8.6 ± 6.36
    -9.5 ± 6.14
    -9.9 ± 7.24
    -9.6 ± 6.65
        SJC (66) at Week 4
    -6.2 ± 10.82
    -6.5 ± 5.07
    -6.3 ± 5.27
    -8.6 ± 9.00
    -6.2 ± 8.00
        SJC (66) at Week 8
    -9.0 ± 10.87
    -8.2 ± 7.03
    -8.5 ± 6.74
    -11.0 ± 8.81
    -10.0 ± 9.92
        SJC (66) at Week 12
    -9.4 ± 9.92
    -9.6 ± 7.76
    -8.8 ± 7.11
    -12.5 ± 9.00
    -11.6 ± 10.19
        TJC (68) at Week 4
    -4.9 ± 11.28
    -8.7 ± 8.96
    -9.1 ± 8.45
    -9.1 ± 12.22
    -7.8 ± 9.60
        TJC (68) at Week 8
    -10.0 ± 13.41
    -10.9 ± 10.48
    -11.3 ± 9.46
    -14.0 ± 14.61
    -12.2 ± 11.40
        TJC (68) at Week 12
    -11.5 ± 12.24
    -13.5 ± 11.44
    -15.5 ± 11.30
    -18.1 ± 15.00
    -14.8 ± 11.98
    Notes
    [111] - Number of Subjects Analyzed at Weeks 4, 8 and 12: 37, 35, 34.
    [112] - Number of Subjects Analyzed at Weeks 4, 8 and 12:38, 35, 31.
    [113] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 45.
    [114] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 45.
    [115] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 47, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Weeks 4, 8 and 12

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    End point title
    Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Weeks 4, 8 and 12 [116]
    End point description
    Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [116] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [117]
    39 [118]
    50 [119]
    50 [120]
    48 [121]
    Units: mg/dL
    least squares mean (confidence interval 95%)
        Week 4
    0.22 (-0.17 to 0.60)
    -0.15 (-0.53 to 0.23)
    -0.66 (-1.00 to -0.32)
    -0.66 (-1.00 to -0.32)
    -0.65 (-1.00 to -0.31)
        Week 8
    0.12 (-0.35 to 0.59)
    0.07 (-0.39 to 0.53)
    -0.91 (-1.31 to -0.50)
    -0.62 (-1.04 to -0.20)
    -0.61 (-1.02 to -0.20)
        Week 12
    -0.07 (-0.54 to 0.39)
    -0.23 (-0.71 to 0.25)
    -0.74 (-1.14 to -0.34)
    -0.68 (-1.09 to -0.27)
    -0.64 (-1.04 to -0.23)
    Notes
    [117] - Number of Subjects Analyzed at Weeks 4, 8 and 12:37, 34, 34.
    [118] - Number of Subjects Analyzed at Weeks 4, 8 and 12:38, 35, 31.
    [119] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 46.
    [120] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 41, 44.
    [121] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 45, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Physician’s Global Assessment of Arthritis (PhGA) at Weeks 4, 8, and 12

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    End point title
    Change From Baseline in the Physician’s Global Assessment of Arthritis (PhGA) at Weeks 4, 8, and 12 [122]
    End point description
    The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease symptoms, functional capacity and physical examination, and was independent of the participant’s reported assessments of PtGA (patient’s global assessment of arthritis). The investigator’s response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled “None” and the 100 mm end labeled “Extreme”.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [122] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [123]
    39 [124]
    50 [125]
    50 [126]
    48 [127]
    Units: units on a scale
    least squares mean (confidence interval 95%)
        Week 4
    -14.30 (-20.06 to -8.54)
    -18.54 (-24.31 to -12.78)
    -22.51 (-27.53 to -17.49)
    -18.34 (-23.34 to -13.33)
    -18.06 (-23.20 to -12.92)
        Week 8
    -25.86 (-32.11 to -19.62)
    -26.80 (-33.12 to -20.48)
    -27.76 (-33.21 to -22.31)
    -27.86 (-33.31 to -22.42)
    -29.97 (-35.42 to -24.52)
        Week 12
    -28.16 (-34.59 to -21.74)
    -30.28 (-36.98 to -23.58)
    -33.05 (-38.61 to -27.49)
    -34.27 (-39.86 to -28.68)
    -36.34 (-41.95 to -30.73)
    Notes
    [123] - Number of Subjects Analyzed at Weeks 4, 8 and 12:37, 35, 34.
    [124] - Number of Subjects Analyzed at Weeks 4, 8 and 12:37, 34, 30.
    [125] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 46.
    [126] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 45.
    [127] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 47, 45.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
    End point description
    AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator.
    End point type
    Secondary
    End point timeframe
    Baseline up to primary completion date (PCD) (about 21 months)
    End point values
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39
    43
    39
    50
    50
    48
    Units: subjects
        TEAEs (all causality)
    17
    17
    20
    27
    19
    23
        TEAEs (treatment-related)
    8
    6
    12
    8
    8
    6
        SAEs (all causality)
    1
    1
    1
    1
    1
    3
        SAEs (treatment-related)
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

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    End point title
    Number of Subjects With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
    End point description
    Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria.
    End point type
    Secondary
    End point timeframe
    Baseline up to PCD (about 21 months)
    End point values
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    38
    43
    39
    50
    50
    48
    Units: subjects
    30
    32
    30
    36
    41
    38
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Signs Data Meeting Pre-sepcified Criteria

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    End point title
    Number of Subjects With Vital Signs Data Meeting Pre-sepcified Criteria
    End point description
    Vital signs tests included systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate. Vital signs categorical summarization criteria were 1), SBP <90 mmHg or change from baseline (Chg) >=30 mmHg; DBP <50 mmHg or Chg >=20 mmHg. 2), pulse rate <40 bpm or >120 bpm.
    End point type
    Secondary
    End point timeframe
    Baseline up to PCD (about 21 months)
    End point values
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    38
    43
    39
    50
    49
    48
    Units: subjects
        Sitting Diastolic BP < 50 mmHg
    1
    0
    0
    0
    0
    0
        Sitting Pulse Rate < 40 bpm
    0
    0
    0
    0
    0
    0
        Sitting Pulse Rate > 120 bpm
    0
    0
    0
    0
    0
    0
        Sitting Systolic BP < 90 mmHg
    0
    0
    0
    0
    0
    0
        Increase: Sitting Systolic BP Chg >= 30 mmHg
    0
    0
    1
    1
    0
    1
        Increase: Sitting Diastolic BP Chg >= 20 mmHg
    1
    2
    3
    0
    1
    2
        Decrease: Sitting Systolic BP Chg >= 30 mmHg
    2
    3
    0
    2
    3
    3
        Decrease: Sitting Diastolic BP Chg >= 20 mmHg
    2
    4
    2
    4
    3
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria

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    End point title
    Number of Subjects With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
    End point description
    ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate (QTc) using Fridericia’s formula (QTcF interval), and QTc calculated using Bazett’s correction factor (QTcB interval).
    End point type
    Secondary
    End point timeframe
    Baseline up to PCD (about 21 months)
    End point values
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    38
    43
    39
    50
    49
    48
    Units: subjects
        PR interval >=300 msec
    0
    0
    0
    0
    0
    0
        QRS duration >=140 msec
    0
    0
    0
    0
    0
    0
        QT interval >=500 msec
    0
    0
    0
    0
    0
    0
        QTcB interval >=450 and <480 msec
    5
    4
    5
    4
    5
    13
        QTcB interval >=480 and <500 msec
    0
    0
    0
    0
    0
    0
        QTcB interval >=500 msec
    0
    0
    0
    0
    0
    0
        QTcF interval >=450 and <480 msec
    0
    1
    1
    0
    1
    4
        QTcF interval >=480 and <500 msec
    0
    0
    0
    0
    0
    0
        QTcF interval >=500 msec
    0
    0
    0
    0
    0
    0
        PR interval increase >=25/50%
    0
    0
    0
    0
    1
    0
        QRS duration increase >=50%
    0
    0
    0
    0
    0
    0
        QTcB interval increase >=30 and increase <60 msec
    3
    6
    9
    3
    4
    7
        QTcB interval increase >=60 msec
    0
    0
    0
    0
    0
    0
        QTcF interval increase >=30 and increase <60 msec
    2
    4
    5
    0
    5
    5
        QTcF interval increase >=60 msec
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Urinalysis Data Meeting Pre-specified Criteria

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    End point title
    Number of Subjects With Urinalysis Data Meeting Pre-specified Criteria
    End point description
    The urine sample was collected for central laboratory urinalysis and urine microscopy. The urinalysis included pH, protein, glucose, erythrocytes, leukocytes, ketones, nitrite, urobilinogen, urine bilirubin, urine hemoglobin, leukocyte esterase, granular casts, hyaline casts, bacteria, atypical, needle-like crystals urine, specific gravity, microscopy and urine albumin test.
    End point type
    Secondary
    End point timeframe
    Baseline up to PCD (about 21 months)
    End point values
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    38
    43
    39
    50
    49
    48
    Units: subjects
        Specific gravity <1.003
    0
    0
    0
    0
    0
    0
        Specific gravity >1.030
    3
    0
    0
    3
    2
    2
        pH <4.5
    0
    0
    0
    0
    0
    0
        pH >8
    0
    0
    0
    0
    0
    0
        Urine glucose >=1
    0
    0
    4
    2
    2
    2
        Ketones >=1
    3
    0
    1
    2
    1
    1
        Urine protein >=1
    0
    0
    0
    0
    1
    0
        Urine hemoglobin >=1
    7
    5
    6
    5
    12
    6
        Urobilinogen >=1
    1
    0
    0
    0
    0
    1
        Urine bilirubin >=1
    0
    0
    0
    0
    0
    0
        Nitrite >=1
    3
    5
    3
    1
    9
    11
        Leukocyte esterase >=1
    16
    15
    14
    14
    19
    19
        Urine erythrocytes(/HPF) >=20
    1
    2
    3
    1
    3
    3
        Urine leukocytes (/HPF) >=20
    4
    3
    2
    2
    7
    7
        Granular casts (/LPF) >1
    1
    1
    0
    0
    0
    0
        Hyaline Casts (/LPF)
    4
    4
    6
    7
    4
    3
        Bacteria >20
    0
    0
    0
    0
    0
    0
        Atypical, needle-like crystals urine >=1
    0
    0
    0
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Patient’s Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12

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    End point title
    Change From Baseline in the Patient’s Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12 [128]
    End point description
    Patients assess the severity of their arthritis pain using a 100 mm 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. This assessment was performed early in the clinic visit and before the subject had had extensive contact with site personnel and/or Investigator.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [128] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [129]
    39 [130]
    50 [131]
    50 [132]
    48 [133]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -12.8 ± 18.85
    -11.5 ± 19.44
    -16.8 ± 20.19
    -9.5 ± 16.10
    -11.3 ± 21.22
        Week 8
    -22.4 ± 20.05
    -15.4 ± 21.32
    -22.2 ± 18.88
    -20.5 ± 23.70
    -23.5 ± 20.42
        Week 12
    -25.9 ± 26.39
    -21.4 ± 25.03
    -23.0 ± 21.46
    -25.7 ± 24.02
    -31.8 ± 23.70
    Notes
    [129] - Number of Subjects Analyzed at Weeks 4, 8 and 12:37, 35, 34.
    [130] - Number of Subjects Analyzed at Weeks 4, 8 and 12:38, 35, 31.
    [131] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 46.
    [132] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 45.
    [133] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 47, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12

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    End point title
    Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12 [134]
    End point description
    Patients answer the following question: “Considering all the ways your arthritis affects you, how are you feeling today?” The patient’s response is recorded using a 100 mm VAS. This assessment was performed early in the clinic visit and before the subject had had extensive contact with site personnel and/or Investigator. The higher score indicated more severe disease.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8 and 12
    Notes
    [134] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [135]
    39 [136]
    49 [137]
    50 [138]
    48 [139]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -12.0 ± 21.55
    -10.0 ± 16.68
    -14.9 ± 20.52
    -10.7 ± 19.11
    -13.7 ± 20.29
        Week 8
    -24.9 ± 21.25
    -13.1 ± 23.47
    -19.6 ± 19.60
    -22.2 ± 27.34
    -25.3 ± 20.74
        Week 12
    -25.9 ± 25.03
    -20.0 ± 23.12
    -19.7 ± 25.71
    -26.5 ± 25.23
    -34.2 ± 22.81
    Notes
    [135] - Number of Subjects Analyzed at Weeks 4, 8 and 12:37, 35, 34.
    [136] - Number of Subjects Analyzed at Weeks 4, 8 and 12:38, 35, 31.
    [137] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 46.
    [138] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 45.
    [139] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 47, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Health Assessment Questionnaire – Disability Index (HAQ-DI) at Weeks 4, 8, and 12

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    End point title
    Change From Baseline in the Health Assessment Questionnaire – Disability Index (HAQ-DI) at Weeks 4, 8, and 12 [140]
    End point description
    The HAQ-DI assesses the degree of difficulty that 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 2-3 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. This questionnaire was performed early in the clinic visit and before the subject had had extensive contact with site personnel and/or Investigator.
    End point type
    Secondary
    End point timeframe
    Baseline Weeks 4, 8 and 12
    Notes
    [140] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [141]
    39 [142]
    50 [143]
    50 [144]
    48 [145]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 4
    -0.2 ± 0.46
    -0.2 ± 0.44
    -0.3 ± 0.40
    -0.2 ± 0.43
    -0.3 ± 0.49
        Week 8
    -0.4 ± 0.47
    -0.4 ± 0.54
    -0.4 ± 0.41
    -0.4 ± 0.56
    -0.5 ± 0.59
        Week 12
    -0.5 ± 0.47
    -0.5 ± 0.60
    -0.5 ± 0.48
    -0.5 ± 0.66
    -0.6 ± 0.59
    Notes
    [141] - Number of Subjects Analyzed at Weeks 4, 8 and 12:37, 35, 34.
    [142] - Number of Subjects Analyzed at Weeks 4, 8 and 12:38, 35, 31.
    [143] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 46.
    [144] - Number of Subjects Analyzed at Weeks 4, 8 and 12:49, 46, 45.
    [145] - Number of Subjects Analyzed at Weeks 4, 8 and 12:47, 47, 45.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12

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    End point title
    Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12 [146]
    End point description
    The SF-36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. This was performed early in the clinic visit and before the subject had had extensive contact with site personnel and/or Investigator.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    Notes
    [146] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [147]
    39 [148]
    50 [149]
    50 [150]
    48 [151]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Physical functioning domain
    3.311 ± 11.5441
    4.885 ± 8.4161
    6.318 ± 8.6700
    5.412 ± 9.7871
    7.322 ± 11.2219
        Role-physical domain
    6.316 ± 9.7393
    5.773 ± 10.0629
    6.173 ± 8.5158
    6.151 ± 9.8448
    6.734 ± 9.3707
        Bodily pain domain
    7.840 ± 7.2950
    6.543 ± 9.3835
    7.280 ± 8.1633
    7.071 ± 9.6901
    10.422 ± 8.6959
        General health domain
    5.775 ± 6.7414
    5.531 ± 6.4448
    4.856 ± 6.5230
    4.916 ± 8.4424
    7.046 ± 8.7992
        Vitality domain
    8.717 ± 8.0179
    7.049 ± 9.9149
    7.354 ± 9.9326
    6.453 ± 10.2902
    8.182 ± 8.7136
        Social function domain
    5.061 ± 11.6125
    6.418 ± 11.6517
    6.430 ± 12.2952
    6.095 ± 12.1659
    8.485 ± 9.2070
        Role-emotional domain
    7.683 ± 11.2028
    4.396 ± 11.1492
    5.103 ± 12.5489
    6.730 ± 12.7335
    6.646 ± 11.4190
        Mental health domain
    7.497 ± 11.8826
    5.161 ± 11.7376
    5.661 ± 13.7839
    7.080 ± 12.9887
    8.866 ± 10.4266
    Notes
    [147] - Number of Subjects Analyzed at Week 12: 34
    [148] - Number of Subjects Analyzed at Week 12: 31
    [149] - Number of Subjects Analyzed at Week 12: 46
    [150] - Number of Subjects Analyzed at Week 12: 45
    [151] - Number of Subjects Analyzed at Week 12: 45
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12

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    End point title
    Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12 [152]
    End point description
    The SF 36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains. These domains can also be summarized as physical component score (PCS) and mental component score (MCS). This was performed early in the clinic visit and before the subject had had extensive contact with site personnel and/or Investigator.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    Notes
    [152] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [153]
    39 [154]
    50 [155]
    50 [156]
    48 [157]
    Units: units on a scale
    arithmetic mean (standard deviation)
        PCS
    4.635 ± 7.8031
    5.728 ± 7.4254
    6.304 ± 7.6091
    5.212 ± 8.0162
    7.476 ± 8.3473
        MCS
    7.995 ± 11.5950
    5.241 ± 10.4860
    5.425 ± 13.6873
    6.749 ± 12.0657
    7.759 ± 9.4263
    Notes
    [153] - Number of Subjects Analyzed at Week 12: 34
    [154] - Number of Subjects Analyzed at Week 12: 31
    [155] - Number of Subjects Analyzed at Week 12: 46
    [156] - Number of Subjects Analyzed at Week 12: 45
    [157] - Number of Subjects Analyzed at Week 12: 45
    No statistical analyses for this end point

    Secondary: Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12

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    End point title
    Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12 [158]
    End point description
    The EQ-5D-3L health state profile is a patient completed questionnaire designed to assess impact on health related quality of life in 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the 5 domains might have been used to calculate a single index value, also known as a utility score. The validity and reliability of the EQ-5D-3L have been established in a number of disease states, including rheumatoid arthritis (RA). This questionnaire was performed early in the clinic visit and before the subject had had extensive contact with site personnel and/or Investigator. The form was checked by site staff for completeness.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    Notes
    [158] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [159]
    39 [160]
    50 [161]
    50 [162]
    48 [163]
    Units: units on a scale
    arithmetic mean (standard deviation)
        EQ visual analogue scale (VAS) score
    13.265 ± 18.8540
    11.129 ± 24.6181
    11.913 ± 20.3795
    20.909 ± 24.5895
    20.778 ± 20.6792
        Index value
    0.132 ± 0.2030
    0.056 ± 0.1957
    0.118 ± 0.1661
    0.143 ± 0.2445
    0.190 ± 0.2201
    Notes
    [159] - Number of Subjects Analyzed at Week 12: 34
    [160] - Number of Subjects Analyzed at Week 12: 31
    [161] - Number of Subjects Analyzed at Week 12: 45
    [162] - Number of Subjects Analyzed at Week 12: 45
    [163] - Number of Subjects Analyzed at Week 12: 45
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12

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    End point title
    Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12 [164]
    End point description
    The FACIT–F is a patient completed questionnaire consisting of 13 items that assess fatigue. Instrument scoring yields a range from 0 to 52, with higher scores representing better patient status (less fatigue). This questionnaire was performed early in the clinic visit and before the subject has extensive contact with site personnel and/or investigator.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    Notes
    [164] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    Placebo PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Number of subjects analysed
    39 [165]
    39 [166]
    50 [167]
    50 [168]
    48 [169]
    Units: units on a scale
        arithmetic mean (standard deviation)
    8.4 ± 8.76
    4.6 ± 10.92
    6.8 ± 8.33
    7.2 ± 11.45
    9.5 ± 9.68
    Notes
    [165] - Number of Subjects Analyzed at Week 12: 34
    [166] - Number of Subjects Analyzed at Week 12: 31
    [167] - Number of Subjects Analyzed at Week 12: 46
    [168] - Number of Subjects Analyzed at Week 12: 45
    [169] - Number of Subjects Analyzed at Week 12: 45
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to PCD (about 21 months)
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. An event may be categorized as serious in 1 subject and as non-serious in another subject, or 1 subject may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of subjects evaluable for SAEs or AEs.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received 4 matching PF-06650833 modified release (MR) placebo tablets once daily (QD) and 1 matching tofacitinib placebo tablet twice a day (BID) in 12 weeks treatment period.

    Reporting group title
    Tofa 10 mg
    Reporting group description
    Subjects received 4 matching PF-06650833 MR placebo tablets QD and 1 tofacitinib 5 mg tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 20 mg
    Reporting group description
    Subjects received 1 MR tablet of PF-06650833 20 mg and 3 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 60 mg
    Reporting group description
    Subjects received 3 MR tablets of PF-06650833 20 mg and 1 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 200 mg
    Reporting group description
    Subjects received 2 MR tablets of PF- 06650833 100 mg and 2 matching PF-06650833 MR placebo tablets QD, 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Reporting group title
    PF-06650833 400 mg
    Reporting group description
    Subjects received 4 MR tablets of PF- 06650833 100 mg QD and 1 matching tofacitinib placebo tablet BID in 12 weeks treatment period.

    Serious adverse events
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 43 (2.33%)
    1 / 39 (2.56%)
    1 / 50 (2.00%)
    1 / 50 (2.00%)
    3 / 48 (6.25%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 48 (2.08%)
         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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 48 (2.08%)
         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
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 48 (2.08%)
         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
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 48 (2.08%)
         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
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    1 / 50 (2.00%)
    0 / 50 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    1 / 48 (2.08%)
         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
    Epididymitis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 48 (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
    Pneumonia bacterial
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    0 / 50 (0.00%)
    0 / 48 (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
    Placebo Tofa 10 mg PF-06650833 20 mg PF-06650833 60 mg PF-06650833 200 mg PF-06650833 400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 39 (25.64%)
    8 / 43 (18.60%)
    12 / 39 (30.77%)
    11 / 50 (22.00%)
    9 / 50 (18.00%)
    11 / 48 (22.92%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
    1 / 50 (2.00%)
    2 / 50 (4.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    1
    0
    1
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    3 / 50 (6.00%)
    0 / 50 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    0
    1
    3
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 43 (2.33%)
    2 / 39 (5.13%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    Abdominal Pain
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 50 (0.00%)
    1 / 50 (2.00%)
    1 / 48 (2.08%)
         occurrences all number
    2
    0
    0
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 43 (2.33%)
    1 / 39 (2.56%)
    4 / 50 (8.00%)
    2 / 50 (4.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    1
    4
    2
    1
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 43 (4.65%)
    4 / 39 (10.26%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    3 / 48 (6.25%)
         occurrences all number
    2
    2
    4
    2
    1
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 43 (4.65%)
    2 / 39 (5.13%)
    0 / 50 (0.00%)
    2 / 50 (4.00%)
    3 / 48 (6.25%)
         occurrences all number
    1
    5
    3
    0
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 43 (6.98%)
    4 / 39 (10.26%)
    2 / 50 (4.00%)
    1 / 50 (2.00%)
    2 / 48 (4.17%)
         occurrences all number
    2
    3
    4
    2
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2016
    The protocol was amended in response to US regulatory feedback to increase the frequency of monitoring for urinary crystals and evidence of acute kidney injury by adding 3 study visits at Weeks 6, 10 and 14.
    28 Nov 2016
    The protocol was updated to allow prior (single) TNF experience after appropriate washout irrespective of inadequate response or due to lack of continued access; updated to clarify exclusion of subjects with alcohol or substance use and with prior active TB and to stipulate that live vaccines were not administered for at least 30 days after the last dose of study medication.
    12 Jul 2017
    Protocol summary and Sections 3, 4.1 and 5.7.1 were updated to clarify that prior use of parenteral MTX was permitted; Inclusion Criterion was updated to increase the recruitment age from 70 to 75 years old; Exclusion Criterion was updated to clarify TB and vaccination exclusion criteria, exclude recruitment of subjects with dermatomyositis and fibromyalgia, define the exclusion based on UACR as >=3 mg/mmol or >=30 mg/g, delete the subject eligibility based on the presence of atypical, needle like, urine crystals on urine microscopy.
    08 Aug 2017
    Protocol summary and section 3 were updated to clarify that methotrexate must have been dosed for at least 3 months to establish “inadequate response” not “lack of inadequate response; added the subject eligibility based on the presence of atypical, needle like, urine crystals on urine microscopy.

    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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