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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Investigate the Safety and Efficacy of CP-690,550 for Induction Therapy in Subjects with Moderate to Severe Crohn’s Disease

    Summary
    EudraCT number
    2011-001733-16
    Trial protocol
    DE   SE   ES   HU   GR   AT   CZ   NL   BG   HR  
    Global end of trial date

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Mar 2016
    First version publication date
    26 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3921083
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01393626
    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., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, 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
    Interim
    Date of interim/final analysis
    23 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2015
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    This Phase 2b, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study evaluated subjects with moderate to severe active Crohn’s disease. The primary objective of the study was to evaluate the dose-response of tofacitinib in inducing clinical remission in subjects with moderate to severe Crohn’s disease and to select effective dose(s). Secondary objectives were to evaluate the safety and tolerability of tofacitinib induction therapy, to evaluate the dose-response of tofacitinib in inducing clinical response, to characterize the pharmacokinetics (PK) of tofacitinib, to evaluate the effect of tofacitinib on quality of life, and to evaluate the effect of tofacitinib on C-reactive protein (CRP) and fecal calprotectin, all in subjects with moderate to severe Crohn’s disease.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. The final protocol and any amendments were reviewed and approved by the Institutional Review Board(s) (IRB) and/or Independent Ethics Committee(s) (IEC) at each of the investigational centres participating in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Japan: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 15
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Ukraine: 10
    Country: Number of subjects enrolled
    United States: 103
    Worldwide total number of subjects
    279
    EEA total number of subjects
    99
    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)
    273
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screening confirmed documented clinical diagnosis of Crohn’s disease (for at least 6 months prior), QuantiFERON® tuberculosis Gold test/chest radiograph, colonoscopy, magnetic resonance imaging & satisfactory laboratory, vital sign, physical examination & 12-lead electrocardiogram results within 1 to 3 weeks prior to Day 1.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo for Tofacitinib (CP-690550)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets to match tofacitinib for oral administration BID for 8 weeks.

    Arm title
    Tofacitinib 5 mg BID
    Arm description
    Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib (CP-690550)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 5 mg tofacitinib tablet for oral administration BID for 8 weeks.

    Arm title
    Tofacitinib 10 mg BID
    Arm description
    Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib (CP-690550)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two 5 mg tofacitinib tablets for oral administration BID for 8 weeks.

    Arm title
    Tofacitinib 15 mg BID
    Arm description
    Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib (CP-690550)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three 5 mg tofacitinib tablets for oral administration BID for 8 weeks.

    Number of subjects in period 1
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Started
    91
    86
    86
    16
    Completed
    73
    74
    74
    15
    Not completed
    18
    12
    12
    1
         Protocol deviation
    1
    -
    2
    -
         Lack of efficacy
    6
    6
    4
    1
         Adverse event, non-fatal
    2
    1
    5
    -
         Unspecified
    1
    -
    -
    -
         Consent withdrawn by subject
    6
    4
    -
    -
         Did not meet entrance criteria
    1
    -
    -
    -
         Lost to follow-up
    1
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.

    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.

    Reporting group title
    Tofacitinib 15 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.

    Reporting group values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID Total
    Number of subjects
    91 86 86 16 279
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    91 85 82 15 273
        From 65-84 years
    0 1 4 1 6
        85 years and over
    0 0 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    37.2 ± 11.7 40.2 ± 11.5 39.3 ± 13.7 41.3 ± 14.3 -
    Gender, Male/Female
    Units: Participants
        Female
    60 32 47 7 146
        Male
    31 54 39 9 133

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.

    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.

    Reporting group title
    Tofacitinib 15 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.

    Primary: Percentage of Participants in Clinical Remission (as Defined by a Crohn’s Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8

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    End point title
    Percentage of Participants in Clinical Remission (as Defined by a Crohn’s Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8 [1]
    End point description
    Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Primary
    End point timeframe
    Week 8
    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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    90
    85
    86
    Units: Percentage of Participants
        number (confidence interval 95%)
    36.67 (26.75 to 47.49)
    43.53 (32.8 to 54.72)
    43.02 (32.39 to 54.15)
    Statistical analysis title
    Analysis of Clinical Remission at Week 8
    Statistical analysis description
    Tofacitinib-Placebo
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.3249
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Mean difference (final values)
    Point estimate
    6.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.64
         upper limit
    21.36
    Statistical analysis title
    Analysis of Clinical Remission at Week 8
    Statistical analysis description
    Tofacitinib-Placebo
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.3916
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Mean difference (final values)
    Point estimate
    6.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.09
         upper limit
    20.8

    Secondary: Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4

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    End point title
    Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 [2]
    End point description
    Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Weeks 2 and 4
    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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    90
    85
    86
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2
    10 (4.68 to 18.14)
    9.41 (4.15 to 17.71)
    9.3 (4.1 to 17.51)
        Week 4
    21.11 (13.21 to 30.99)
    24.71 (15.99 to 35.25)
    22.09 (13.86 to 32.33)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points from Baseline) at Weeks 2, 4, and 8

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    End point title
    Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points from Baseline) at Weeks 2, 4, and 8 [3]
    End point description
    Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and 8
    Notes
    [3] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    90
    85
    86
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2
    37.78 (27.77 to 48.62)
    47.06 (36.13 to 58.19)
    44.19 (33.48 to 55.3)
        Week 4
    50 (39.27 to 60.73)
    57.65 (46.45 to 68.3)
    56.98 (45.85 to 67.61)
        Week 8
    62.22 (51.38 to 72.23)
    76.47 (66.03 to 85)
    74.42 (63.87 to 83.22)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points from Baseline) at Weeks 2, 4, and 8

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    End point title
    Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points from Baseline) at Weeks 2, 4, and 8 [4]
    End point description
    Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and 8
    Notes
    [4] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    90
    85
    86
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2
    23.33 (15.06 to 33.43)
    34.12 (24.18 to 45.2)
    32.56 (22.84 to 43.52)
        Week 4
    37.78 (27.77 to 48.62)
    48.24 (37.26 to 59.34)
    45.35 (34.58 to 56.45)
        Week 8
    54.44 (43.6 to 64.98)
    70.59 (59.71 to 79.98)
    68.6 (57.7 to 78.19)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8

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    End point title
    Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8 [5]
    End point description
    Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, and 8
    Notes
    [5] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    90
    85
    86
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2
    24.44 (16 to 34.64)
    34.12 (24.18 to 45.2)
    32.56 (22.84 to 43.52)
        Week 4
    38.89 (28.79 to 49.74)
    49.41 (38.39 to 60.48)
    46.51 (35.68 to 57.59)
        Week 8
    55.56 (44.7 to 66.04)
    71.76 (60.96 to 81)
    69.77 (58.92 to 79.21)
    No statistical analyses for this end point

    Secondary: CDAI Scores at Weeks 2, 4, and 8

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    End point title
    CDAI Scores at Weeks 2, 4, and 8
    End point description
    CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 8
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    90
    85
    86
    16
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 2 (n=85, 78, 77, 16)
    258.04 ± 89.79
    237.6 ± 67.87
    241.21 ± 75.27
    270.31 ± 90.78
        Week 4 (n=81, 78, 71, 15)
    228.65 ± 102.01
    213.38 ± 86.04
    203.58 ± 86.69
    228.27 ± 103.01
        Week 8 (n=80, 77, 75, 15)
    194.9 ± 111.88
    162.77 ± 87.67
    159.08 ± 81.3
    172.47 ± 119.28
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8

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    End point title
    C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 8
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    90
    85
    86
    16
    Units: Milligrams per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 2 (n=89, 84, 81, 16)
    17.28 ± 23.07
    8.26 ± 11.4
    8.56 ± 14.03
    7.89 ± 9.42
        Week 4 (n=83, 82, 78, 16)
    18.94 ± 31.26
    8.17 ± 10.6
    9.48 ± 21.35
    10.33 ± 16.8
        Week 8 (n=80, 77, 74, 15)
    18.12 ± 26.42
    9.49 ± 15.33
    6.55 ± 11
    5.77 ± 7.74
    No statistical analyses for this end point

    Secondary: Calprotectin Fecal Concentrations at Weeks 2, 4, and 8

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    End point title
    Calprotectin Fecal Concentrations at Weeks 2, 4, and 8
    End point description
    Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 8
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    90
    85
    86
    16
    Units: mg per kilogram (mg/kg)
    arithmetic mean (standard deviation)
        Week 2 (n=81, 76, 73, 16)
    492.95 ± 664.51
    384.81 ± 342.9
    403.35 ± 352.57
    455.1 ± 461.87
        Week 4 (n=81, 82, 71, 16)
    493.26 ± 682.81
    467.09 ± 377.65
    359.3 ± 306.88
    338.11 ± 391.65
        Week 8 (n=75, 66, 72, 14)
    428.45 ± 479.36
    417.7 ± 336.75
    385.66 ± 316.71
    349.61 ± 365.37
    No statistical analyses for this end point

    Secondary: Tofacitinib Plasma Concentrations from 0 to 2 hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit

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    End point title
    Tofacitinib Plasma Concentrations from 0 to 2 hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit [6]
    End point description
    Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different. 9999 indicates number of observations above the lower limit of quantification equals (=) 0.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit
    Notes
    [6] - 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: Only participants from “Tofacitinib” treatment arms were planned to be analysed for this end point.
    End point values
    Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    85
    86
    16
    Units: nanograms per milliliter
    arithmetic mean (standard deviation)
        Day 1, 0 hours (n=83, 83, 16)
    0.006687 ± 0.049144
    1.193 ± 9.0312
    9999 ± 9999
        Day 1, 20 minutes (n=82, 83, 16)
    27.44 ± 27.335
    62.28 ± 60.795
    65.83 ± 63.232
        Day 1, 40 minutes (n=82, 81, 16)
    41.03 ± 24.21
    84.61 ± 47.47
    151.4 ± 61.288
        Day 1, 1 hour (n=83, 83, 16)
    41.22 ± 18.432
    82.48 ± 40.782
    149.9 ± 42.22
        Day 1, 2 hours (n=83, 82, 16)
    31.85 ± 12.442
    70.01 ± 24.838
    106.1 ± 26.661
        Week 8/ET, 0 hours (n=78, 72, 13)
    4.216 ± 7.1089
    11.57 ± 21.453
    23.89 ± 45.837
        Week 8/ET, 20 minutes (n=70, 70, 12)
    25.89 ± 21.485
    71.14 ± 54.969
    127.6 ± 89.861
        Week 8/ET, 40 minutes (n=70, 69, 12)
    37.75 ± 23.891
    93.09 ± 46.471
    148.7 ± 58.948
        Week 8/ET, 1 hour (n=70, 69, 12)
    37.47 ± 21.384
    83.14 ± 35.1
    144.7 ± 48.137
        Week 8/ET, 2 hours (n=72, 70, 13)
    27.61 ± 15.742
    62.38 ± 27.505
    92.03 ± 27.806
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit

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    End point title
    Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit
    End point description
    The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. Number of Subjects Analysed is the number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    88
    84
    81
    16
    Units: Score on a scale
    arithmetic mean (standard deviation)
        IBDQ Total Score, Baseline
    118.5 ± 28.48
    117.89 ± 27.98
    113.67 ± 28.45
    124.19 ± 26.97
        IBDQ Total Score, Week 8/ET
    144.99 ± 37.97
    159.14 ± 35.39
    156.64 ± 36.66
    159 ± 47.98
        Bowel Function Score, Baseline
    37.78 ± 8.17
    37.39 ± 9.37
    36.29 ± 7.72
    37.5 ± 9.78
        Bowel Function Score, Week 8/ET
    45.76 ± 12.19
    50.94 ± 11.02
    50.69 ± 11.02
    52.5 ± 13.81
        Emotional Status Score, Baseline
    45.88 ± 13.04
    45.34 ± 13.27
    44.55 ± 13.27
    47.25 ± 10.41
        Emotional Status Score, Week 8/ET
    56.31 ± 14.39
    59.54 ± 13.78
    58.32 ± 14.71
    57.25 ± 20.07
        Systemic Symptoms Score, Baseline
    15.22 ± 5.24
    15.58 ± 4.36
    14.6 ± 4.78
    16.44 ± 5.35
        Systemic Symptoms Score, Week 8/ET
    19.7 ± 6.51
    22.24 ± 6.3
    21.8 ± 6.27
    22.88 ± 7.05
        Social Function Score, Baseline
    19.62 ± 7.28
    19.48 ± 6.62
    18.23 ± 7.09
    23 ± 6.29
        Social Function Score, Week 8/ET
    23.23 ± 8.47
    26.43 ± 7.57
    25.83 ± 7.8
    26.38 ± 9.58
    No statistical analyses for this end point

    Secondary: Change from Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)

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    End point title
    Change from Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA) [7]
    End point description
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors.The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size. Number of Subjects Analysed is the maximum number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    Notes
    [7] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    88
    84 [8]
    81
    Units: Score on a scale
    arithmetic mean (standard error)
        IBDQ Total Score
    26.58 ± 3.76
    41.2 ± 3.9
    40.05 ± 3.9
        Bowel Function Score
    8.36 ± 1.23
    13.76 ± 1.28
    13.88 ± 1.28
        Emotional Status Score
    10.33 ± 1.37
    13.87 ± 1.42
    12.54 ± 1.43
        Systemic Symptoms Score
    4.41 ± 0.66
    6.7 ± 0.69
    6.68 ± 0.69
        Social Function Score
    3.68 ± 0.79
    7.03 ± 0.82
    6.95 ± 0.82
    Notes
    [8] - (Number of subjects analysed for Social Function Score = 83)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an IBDQ Total Score of Greater than or Equal to (≥) 170 at Week 8/ET Visit

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    End point title
    Percentage of Participants with an IBDQ Total Score of Greater than or Equal to (≥) 170 at Week 8/ET Visit
    End point description
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.
    End point type
    Secondary
    End point timeframe
    Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    88
    84
    81
    16
    Units: Percentage of Participants
        number (not applicable)
    26.1
    45.2
    43.2
    43.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥16 Point Increase from Baseline in IBDQ Total Score at Week 8/ET Visit

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    End point title
    Percentage of Participants with ≥16 Point Increase from Baseline in IBDQ Total Score at Week 8/ET Visit
    End point description
    The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.
    End point type
    Secondary
    End point timeframe
    Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    88
    84
    81
    16
    Units: Percentage of Participants
        number (not applicable)
    61.4
    75
    76.5
    75
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category

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    End point title
    Percentage of Participants with a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category
    End point description
    The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.
    End point type
    Secondary
    End point timeframe
    Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    90
    85
    86
    16
    Units: Percentage of Participants
    number (not applicable)
        PSA: Extremely dissatisfied
    17
    6
    7.4
    6.3
        PSA: Dissatisfied
    10.2
    9.6
    6.2
    0
        PSA: Neither satisfied nor dissatisfied
    25
    19.3
    16
    25
        PSA: Satisfied
    40.9
    45.8
    43.2
    25
        PSA: Extremely satisfied
    6.8
    19.3
    27.2
    43.8
        PPTA: Injectable prescription medicines
    42
    39.5
    22.2
    37.5
        PPTA: Prescription medicines taken by mouth
    37.5
    44.4
    56.8
    43.8
        PPTA: Surgery
    2.3
    2.5
    0
    0
        PPTA: Prescription medicines and surgery
    5.7
    7.4
    8.6
    6.3
        PPTA: No treatment
    12.5
    6.2
    12.3
    12.5
        PPA: Definitely prefer the drug I receive now
    33
    42.2
    48.1
    56.3
        PPA: Slight preference for drug I'm receiving now
    19.3
    27.7
    22.2
    25
        PPA: I have no preference either way
    28.4
    19.3
    13.6
    18.8
        PPA: Slight preference for previous treatment
    9.1
    2.4
    7.4
    0
        PPA: No, definitely prefer my previous treatment
    10.2
    8.4
    8.6
    0
        PWA: Would definitely want to use same drug again
    44.3
    53
    61.7
    50
        PWA: Might want to use the same drug again
    11.4
    24.1
    17.3
    37.5
        PWA: I am not sure
    20.5
    10.8
    8.6
    6.3
        PWA: Might not want to use same drug again
    6.8
    2.4
    4.9
    0
        PWA: Definitely not want to use same drug again
    17
    9.6
    7.4
    6.3
    No statistical analyses for this end point

    Secondary: Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit

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    End point title
    Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit
    End point description
    The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    87
    84
    81
    16
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Physical component score, Baseline
    37.12 ± 7.66
    38.49 ± 6.78
    35.28 ± 8.49
    37.09 ± 9.14
        Physical component score, Week 8/ET
    40.84 ± 9.23
    45.23 ± 8.85
    44.29 ± 9.41
    47.01 ± 7.97
        Mental Component Score, Baseline
    36.5 ± 12.26
    34.85 ± 11.68
    35.84 ± 10.68
    39.26 ± 11.85
        Mental Component Score, Week 8/ET
    42.46 ± 11.21
    43.69 ± 12.15
    43.65 ± 11.87
    42.73 ± 16.37
        Physical Functioning Domain, Baseline
    43.73 ± 8.93
    43.56 ± 8.81
    41.36 ± 10.03
    42.66 ± 9.04
        Physical Functioning Domain, Week 8/ET
    46.55 ± 8.93
    49.68 ± 8.43
    48.37 ± 8.78
    49.57 ± 8.99
        Role Physical Domain, Baseline
    35.34 ± 9.94
    36.36 ± 9.71
    32.57 ± 10.92
    37.68 ± 12.43
        Role Physical Domain, Week 8/ET
    39.92 ± 10.64
    44.49 ± 11.52
    42.84 ± 11.59
    44.39 ± 13.18
        Bodily Pain Domain, Baseline
    34.69 ± 8.79
    35.22 ± 8.44
    33.32 ± 8.25
    34.98 ± 8.23
        Bodily Pain Domain, Week 8/ET
    40.81 ± 10.43
    44.68 ± 11.29
    45.1 ± 10.41
    47.61 ± 11.21
        General Health Domain, Baseline
    30.58 ± 7.21
    31.37 ± 7.15
    29.56 ± 7.52
    32.08 ± 12.42
        General Health Domain, Week 8/ET
    34.36 ± 8.5
    36.79 ± 8.53
    37.19 ± 10.75
    37.98 ± 13.51
        Vitality Domain, Baseline
    35.06 ± 9.7
    34.66 ± 7.86
    35.8 ± 9.05
    37.55 ± 11.88
        Vitality Domain, Week 8/ET
    41.2 ± 11.45
    45.22 ± 11.94
    44.6 ± 12.53
    48.77 ± 13.41
        Social Functioning Domain, Baseline
    34.71 ± 11.83
    35.53 ± 11.69
    33.83 ± 11.36
    35.9 ± 10.61
        Social Functioning Domain, Week 8/ET
    40.02 ± 12.33
    45.01 ± 11.79
    43.46 ± 11.43
    43.63 ± 14.94
        Role Emotional Domain, Baseline
    38.45 ± 13.98
    37.2 ± 12.96
    35.34 ± 13.23
    39.12 ± 14.02
        Role Emotional Domain, Week 8/ET
    43.06 ± 12.43
    44.77 ± 12.46
    43.76 ± 11.94
    42.9 ± 16.58
        Mental Health Domain, Baseline
    37.6 ± 12.3
    35.95 ± 11.38
    36.98 ± 11.09
    41.27 ± 10.27
        Mental Health Domain, Week 8/ET
    43.75 ± 11.02
    43.58 ± 11.67
    44.76 ± 11.64
    43 ± 15.96
    No statistical analyses for this end point

    Secondary: Change from Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA

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    End point title
    Change from Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA [9]
    End point description
    The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    Notes
    [9] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    87
    84
    81
    Units: Score on a Scale
    arithmetic mean (standard error)
        Physical component score
    3.72 ± 0.927
    7.28 ± 0.967
    8.07 ± 0.956
        Mental Component Score
    6.47 ± 1.143
    7.88 ± 1.178
    7.13 ± 1.18
        Physical Functioning Domain
    3.01 ± 0.85
    6.14 ± 0.876
    5.59 ± 0.876
        Role Physical Domain
    5.02 ± 1.152
    8.76 ± 1.191
    8.95 ± 1.183
        Bodily Pain Domain
    6.41 ± 1.132
    9.94 ± 1.174
    11.1 ± 1.171
        General Health Domain
    3.62 ± 0.897
    5.55 ± 0.937
    7.03 ± 0.933
        Vitality Domain
    5.55 ± 1.19
    9.84 ± 1.225
    8.05 ± 1.233
        Social Functioning Domain
    5.25 ± 1.163
    9.72 ± 1.206
    8.66 ± 1.204
        Role Emotional Domain
    5.59 ± 1.222
    7.28 ± 1.257
    7.14 ± 1.26
        Mental Health Domain
    6.46 ± 1.1
    7.05 ± 1.136
    7.41 ± 1.134
    No statistical analyses for this end point

    Secondary: EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit

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    End point title
    EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit
    End point description
    EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state. Number of Subjects Analysed is the maximum number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    89
    85
    86
    16
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Utility Score, Baseline (n=89, 85, 86, 16)
    0.56 ± 0.29
    0.58 ± 0.26
    0.49 ± 0.31
    0.61 ± 0.24
        Utility Score, Week 8/ET (n=85, 84, 80, 16)
    0.64 ± 0.27
    0.71 ± 0.28
    0.71 ± 0.27
    0.77 ± 0.3
    No statistical analyses for this end point

    Secondary: Change from Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA

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    End point title
    Change from Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA [10]
    End point description
    EQ-5D: a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors.The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    Notes
    [10] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    84
    84
    80
    Units: Score on a Scale
        arithmetic mean (standard error)
    0.08 ± 0.029
    0.14 ± 0.03
    0.16 ± 0.03
    No statistical analyses for this end point

    Secondary: EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit

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    End point title
    EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
    End point description
    EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Number of Subjects Analysed is the maximum number of participants with non-missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Number of subjects analysed
    90
    85
    86
    16
    Units: mm
    arithmetic mean (standard deviation)
        VAS Score, Baseline (n=90, 85, 86, 16)
    46.83 ± 18.63
    49.51 ± 18.03
    42.74 ± 18.04
    52.06 ± 24.11
        VAS Score, Week 8/ET (n=85, 83, 81, 16)
    58.32 ± 21.31
    67.07 ± 19.39
    65.77 ± 19.71
    69.81 ± 21.11
    No statistical analyses for this end point

    Secondary: Change from Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA

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    End point title
    Change from Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA [11]
    End point description
    EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8/ET visit
    Notes
    [11] - 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: The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    85
    83
    81
    Units: mm
        arithmetic mean (standard error)
    11.97 ± 2.166
    19.56 ± 2.252
    20.62 ± 2.222
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were assessed from informed consent through and including 28 calendar days after last administration of study treatment (i.e. 11 weeks). Non-SAEs were recorded from time of first dose of study treatment through last participant visit (i.e. 15 weeks).
    Adverse event reporting additional description
    The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.

    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.

    Reporting group title
    Tofacitinib 15 mg BID
    Reporting group description
    Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.

    Serious adverse events
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 91 (3.30%)
    3 / 86 (3.49%)
    10 / 86 (11.63%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn’s disease
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    3 / 86 (3.49%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urethral
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Tofacitinib 15 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 91 (47.25%)
    37 / 86 (43.02%)
    42 / 86 (48.84%)
    9 / 16 (56.25%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 91 (1.10%)
    4 / 86 (4.65%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences all number
    1
    4
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    2
    0
    Chills
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Fatigue
         subjects affected / exposed
    1 / 91 (1.10%)
    3 / 86 (3.49%)
    3 / 86 (3.49%)
    0 / 16 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Pyrexia
         subjects affected / exposed
    3 / 91 (3.30%)
    2 / 86 (2.33%)
    5 / 86 (5.81%)
    1 / 16 (6.25%)
         occurrences all number
    3
    2
    5
    1
    Tenderness
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed [1]
    1 / 60 (1.67%)
    0 / 86 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 86 (2.33%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    2
    1
    Blood triglycerides increased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 91 (1.10%)
    4 / 86 (4.65%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 91 (3.30%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    3
    1
    3
    0
    Headache
         subjects affected / exposed
    7 / 91 (7.69%)
    8 / 86 (9.30%)
    5 / 86 (5.81%)
    1 / 16 (6.25%)
         occurrences all number
    9
    8
    5
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 91 (5.49%)
    3 / 86 (3.49%)
    7 / 86 (8.14%)
    2 / 16 (12.50%)
         occurrences all number
    5
    5
    9
    2
    Abdominal distension
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    3 / 86 (3.49%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Abdominal tenderness
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Anal fistula
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 86 (2.33%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Aphthous stomatitis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    2
    Constipation
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    1
    Crohn’s disease
         subjects affected / exposed
    6 / 91 (6.59%)
    5 / 86 (5.81%)
    4 / 86 (4.65%)
    1 / 16 (6.25%)
         occurrences all number
    6
    7
    4
    2
    Diarrhoea
         subjects affected / exposed
    3 / 91 (3.30%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    3
    1
    0
    4
    Dyspepsia
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Flatulence
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Nausea
         subjects affected / exposed
    8 / 91 (8.79%)
    5 / 86 (5.81%)
    7 / 86 (8.14%)
    0 / 16 (0.00%)
         occurrences all number
    8
    5
    7
    0
    Stomatitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 86 (1.16%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 91 (1.10%)
    4 / 86 (4.65%)
    5 / 86 (5.81%)
    0 / 16 (0.00%)
         occurrences all number
    1
    4
    5
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 86 (2.33%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 86 (2.33%)
    2 / 86 (2.33%)
    1 / 16 (6.25%)
         occurrences all number
    3
    2
    2
    1
    Back pain
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Joint swelling
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 86 (2.33%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Pain in extremity
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 86 (1.16%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    3 / 86 (3.49%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Folliculitis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    2 / 86 (2.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 91 (2.20%)
    1 / 86 (1.16%)
    1 / 86 (1.16%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 91 (3.30%)
    3 / 86 (3.49%)
    6 / 86 (6.98%)
    0 / 16 (0.00%)
         occurrences all number
    3
    4
    6
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 91 (1.10%)
    2 / 86 (2.33%)
    1 / 86 (1.16%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    1
    Oral herpes
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 86 (0.00%)
    0 / 86 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 86 (1.16%)
    2 / 86 (2.33%)
    4 / 16 (25.00%)
         occurrences all number
    6
    1
    2
    5
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants were counted as exposed to this adverse event of ovarian cyst.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2011
    Amendment 1 was country-specific to Japan and added specific safety screening and monitoring requirements.
    07 Sep 2011
    Amendment 2 corrected an error in the first question of the CDAI (the primary endpoint assessment tool) to add the word “very,” which had been inadvertently omitted, before the words “soft stools.” Language regarding publication policy was also added to meet requirements for all countries involved in this study. The opportunity was then taken to also correct other minor typographical errors and clarify some language that was felt to be imprecise or unclear in the protocol.
    02 Jul 2012
    Amendment 3 was a country-specific amendment for India and the Netherlands that excluded subjects over 65 years of age.
    28 Sep 2012
    Amendment 4 updated standard Pfizer protocol text, including safety language in various sections. An updated prohibited medication table was also included, as were lymphocyte count requirements for subject selection and monitoring, discontinuation criteria for lymphopenia, guidance regarding surgery during the study, and updates to the background section.
    16 Nov 2012
    Amendment 5 removed the tofacitinib 15 mg BID dose group and updated the statistical methods and dose rationale sections accordingly. This amendment also revised the country-specific upper age limit for India.

    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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