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

    Summary
    EudraCT number
    2011-001754-28
    Trial protocol
    DE   SE   HU   ES   AT   NL   CZ   GR   BG   HR  
    Global end of trial date
    29 Jul 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Jul 2016
    First version publication date
    22 Jul 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    A3921084
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01393899
    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
    Final
    Date of interim/final analysis
    29 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the effects of tofacitinib in maintaining clinical response or clinical remission in subjects with moderate to severe Crohn’s disease (CD) who previously achieved clinical response or clinical remission at Week 8 in the induction Study A3921083
    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.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Mar 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Hungary: 18
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    United States: 61
    Worldwide total number of subjects
    180
    EEA total number of subjects
    63
    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)
    176
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 180 subjects were randomized to the study

    Pre-assignment
    Screening details
    Baseline visit for this study took place on the same day as the Study A3921083 Week 8 visit. Participants who achieved clinical response-100 and/or clinical remission after completion of the 8-week induction therapy in Study A3921083 and who fulfilled the inclusion/exclusion criteria were randomly assigned to 1 of 3 treatments of this 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, Monitor, Subject, Carer, Data analyst, Assessor
    Blinding implementation details
    Study treatment assignment was blinded to participants, investigators, and the sponsor. Assignment of participant identification number and study drug, site drug inventory control and emergency unblinding, were managed through a telerandomization tool. At the initiation of the study, the study site was instructed on how to use the telerandomization tool to break the blind, and each study site was provided a manual containing complete instructions for web or telephone access.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two placebo tablets were administered orally BID for 26 weeks.

    Arm title
    Tofacitinib 5 mg BID
    Arm description
    Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) were administered orally BID for 26 weeks.

    Arm title
    Tofacitinib 10 mg BID
    Arm description
    Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tofacitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tofacitinib 10 mg (two tofacitinib tablets) were administered orally BID for 26 weeks.

    Number of subjects in period 1
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Started
    59
    60
    61
    Completed
    27
    32
    38
    Not completed
    32
    28
    23
         Does not meet entrance criteria
    1
    -
    1
         Lack of efficacy
    26
    21
    16
         Study terminated by sponsor
    1
    -
    1
         Adverse event, non-fatal
    1
    5
    3
         Consent withdrawn by subject
    2
    2
    1
         Unspecified
    1
    -
    -
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.

    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

    Reporting group values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID Total
    Number of subjects
    59 60 61 180
    Age, Customized
    Units: Participants
        Less than or equal to (<=)18 years
    0 0 0 0
        Between 18 and 44 years
    34 44 40 118
        Between 45 and 64 years
    23 15 20 58
        More than or equal to (>=)65 years
    2 1 1 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.5 ± 12.8 38.1 ± 11.9 39 ± 13.1 -
    Gender, Male/Female
    Units: Participants
        Female
    32 30 24 86
        Male
    27 30 37 94

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.

    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

    Primary: Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn’s Disease Activity Index [CDAI] Score of at Least 100 Points from Baseline) or Clinical Remission (CDAI Score less than [<]150) at Week 26

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    End point title
    Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn’s Disease Activity Index [CDAI] Score of at Least 100 Points from Baseline) or Clinical Remission (CDAI Score less than [<]150) at Week 26
    End point description
    Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <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 anti-diarrheal 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.
    End point type
    Primary
    End point timeframe
    Week 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
        number (confidence interval 80%)
    38.1 (27.94 to 49.16)
    39.53 (29.39 to 50.46)
    55.81 (44.92 to 66.28)
    Statistical analysis title
    Analysis of Clinical Response-100
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.44
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -12.11
         upper limit
    14.99
    Statistical analysis title
    Analysis of Clinical Response-100
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Median difference (final values)
    Point estimate
    17.72
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    4.07
         upper limit
    31.37

    Secondary: Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20

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    End point title
    Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
    End point description
    Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <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 extraintestinal symptoms, need for anti-diarrheal 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 4, 8, 12 and 20
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
    number (confidence interval 80%)
        Week 4
    73.81 (63.16 to 82.62)
    74.42 (63.96 to 83.05)
    79.07 (68.98 to 86.96)
        Week 8
    66.67 (55.69 to 76.37)
    67.44 (56.64 to 76.95)
    58.14 (47.22 to 68.46)
        Week 12
    50 (39.12 to 60.88)
    55.81 (44.92 to 66.28)
    53.49 (42.64 to 64.08)
        Week 20
    40.48 (30.13 to 51.55)
    39.53 (29.39 to 50.46)
    51.16 (40.38 to 61.86)
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.61
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -11.57
         upper limit
    12.79
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.78
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -12.29
         upper limit
    13.84
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.81
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -8.04
         upper limit
    19.67
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.94
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -14.56
         upper limit
    12.68
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.26
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -6.52
         upper limit
    17.04
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.53
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -21.94
         upper limit
    4.88
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    3.49
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -10.4
         upper limit
    17.37
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    10.69
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -3.08
         upper limit
    24.46

    Secondary: Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26

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    End point title
    Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
    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 extraintestinal symptoms, need for anti-diarrheal 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 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
    number (confidence interval 80%)
        Week 4
    73.81 (63.16 to 82.62)
    72.09 (61.49 to 81.04)
    76.74 (66.45 to 85.02)
        Week 8
    66.67 (55.69 to 76.37)
    62.79 (51.88 to 72.75)
    58.14 (47.22 to 68.46)
        Week 12
    50 (39.12 to 60.88)
    55.81 (44.92 to 66.28)
    51.16 (40.38 to 61.86)
        Week 20
    38.1 (27.94 to 49.16)
    39.53 (29.39 to 50.46)
    51.16 (40.38 to 61.86)
        Week 26
    35.71 (25.77 to 46.74)
    37.21 (27.25 to 48.12)
    55.81 (44.92 to 66.28)
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.72
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -14.06
         upper limit
    10.63
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.88
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -17.15
         upper limit
    9.4
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.81
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -8.04
         upper limit
    19.67
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.44
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -12.11
         upper limit
    14.99
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -11.88
         upper limit
    14.87
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    2.93
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -9.06
         upper limit
    14.92
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.53
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -21.94
         upper limit
    4.88
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.16
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -12.74
         upper limit
    15.06
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    13.07
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -0.63
         upper limit
    26.77
    Statistical analysis title
    Analysis of Clinical Response-100
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    20.1
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    6.54
         upper limit
    33.66

    Secondary: Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26

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    End point title
    Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
    End point description
    Clinical remission was a CDAI score <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 extraintestinal symptoms, need for anti-diarrheal 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 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
    number (confidence interval 80%)
        Week 4
    52.38 (41.42 to 63.16)
    55.81 (44.92 to 66.28)
    58.14 (47.22 to 68.46)
        Week 8
    47.62 (36.84 to 58.58)
    48.84 (38.14 to 59.62)
    39.53 (29.39 to 50.46)
        Week 12
    33.33 (23.63 to 44.31)
    46.51 (35.92 to 57.36)
    34.88 (25.14 to 45.75)
        Week 20
    30.95 (21.52 to 41.84)
    32.56 (23.05 to 43.36)
    39.53 (29.39 to 50.46)
        Week 26
    28.57 (19.43 to 39.35)
    37.21 (27.25 to 48.12)
    41.86 (31.54 to 52.78)
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    3.43
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -10.41
         upper limit
    17.28
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.22
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -12.67
         upper limit
    15.11
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    13.18
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -0.31
         upper limit
    26.67
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.61
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -11.33
         upper limit
    14.55
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    8.64
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -4.36
         upper limit
    21.64
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    5.76
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -8.04
         upper limit
    19.56
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.08
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -21.83
         upper limit
    5.66
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.55
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -11.63
         upper limit
    14.73
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    8.58
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -4.64
         upper limit
    21.81
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    13.29
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    0.15
         upper limit
    26.43

    Secondary: Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study

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    End point title
    Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
    End point description
    Clinical remission was a CDAI score <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 extraintestinal symptoms, need for anti-diarrheal 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 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    25
    28
    26
    Units: Percentage of participants
    number (confidence interval 80%)
        Week 4
    72 (57.42 to 83.68)
    78.57 (65.41 to 88.34)
    80.77 (67.23 to 90.34)
        Week 8
    64 (49.2 to 76.97)
    64.29 (50.42 to 76.5)
    50 (35.93 to 64.07)
        Week 12
    40 (26.53 to 54.77)
    64.29 (50.42 to 76.5)
    42.31 (28.86 to 56.71)
        Week 20
    36 (23.03 to 50.8)
    42.86 (29.87 to 56.67)
    46.15 (32.36 to 60.43)
        Week 26
    28 (16.32 to 42.58)
    39.29 (26.65 to 53.16)
    50 (35.93 to 64.07)
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    6.57
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -8.63
         upper limit
    21.78
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.29
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -16.63
         upper limit
    17.2
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    24.29
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    7.19
         upper limit
    41.38
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    6.86
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -10.32
         upper limit
    24.03
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    11.29
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -5.22
         upper limit
    27.79
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    8.77
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -6.41
         upper limit
    23.95
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -14
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -31.59
         upper limit
    3.59
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    2.31
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -15.35
         upper limit
    19.97
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    10.15
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -7.41
         upper limit
    27.71
    Statistical analysis title
    Analysis of Clinical Remission
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    22
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    4.96
         upper limit
    39.04

    Secondary: Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at both Weeks 20 and 26) in the Maintenance Phase

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    End point title
    Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at both Weeks 20 and 26) in the Maintenance Phase
    End point description
    Clinical remission was a CDAI score <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 extraintestinal symptoms, need for anti-diarrheal 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 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
        number (confidence interval 80%)
    21.43 (13.37 to 31.71)
    23.26 (14.98 to 33.55)
    39.53 (29.39 to 50.46)
    Statistical analysis title
    Analysis of Clinical Remission
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.83
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -9.75
         upper limit
    13.4
    Statistical analysis title
    Analysis of Clinical Remission
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    18.11
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    5.57
         upper limit
    30.64

    Secondary: Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at least a Clinical Response-100 at both Weeks 20 and 26 from the A3921083 Baseline) in the Maintenance Phase

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    End point title
    Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at least a Clinical Response-100 at both Weeks 20 and 26 from the A3921083 Baseline) in the Maintenance Phase
    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.
    End point type
    Secondary
    End point timeframe
    Weeks 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
        number (confidence interval 80%)
    33.33 (23.63 to 44.31)
    25.58 (16.95 to 36.04)
    51.16 (40.38 to 61.86)
    Statistical analysis title
    Analysis of Clinical Response-100
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.75
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -20.39
         upper limit
    4.88
    Statistical analysis title
    Analysis of Clinical Response-100
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    17.83
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    4.33
         upper limit
    31.33

    Secondary: CDAI Score by Week

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    End point title
    CDAI Score by Week
    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 wellbeing, occurrence of extraintestinal 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
    Baseline and Weeks 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline
    135.05 ± 69.83
    127.23 ± 60.46
    133.98 ± 63.31
        Week 4
    168.24 ± 103.18
    133.48 ± 89.94
    143.45 ± 84.26
        Week 8
    171.87 ± 109.18
    149.78 ± 99.56
    165.69 ± 95.46
        Week 12
    181.38 ± 108.68
    158.56 ± 119.41
    152.93 ± 82.77
        Week 20
    161.76 ± 91.65
    151.74 ± 106.09
    112.32 ± 85.47
        Week 26
    137.05 ± 77.65
    134.77 ± 80.22
    110.77 ± 76.3
    No statistical analyses for this end point

    Secondary: Change from Baseline in CDAI Score by Week

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    End point title
    Change from Baseline in CDAI Score by Week
    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 wellbeing, occurrence of extraintestinal 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 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 4
    33.17 ± 76.41
    5.85 ± 69.52
    11.02 ± 72.22
        Week 8
    39.85 ± 83.68
    20.32 ± 69.59
    35.83 ± 101.96
        Week 12
    52.81 ± 113.91
    32.29 ± 88.35
    24.07 ± 84.46
        Week 20
    32.44 ± 96.18
    36.83 ± 90.92
    -14.36 ± 78.58
        Week 26
    1.5 ± 93.91
    17.36 ± 79.81
    -16.35 ± 75.65
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0637
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -30.26
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -51.1
         upper limit
    -9.42
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.3054
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -21.06
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -47.43
         upper limit
    5.31
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1316
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -42.52
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -78.57
         upper limit
    -6.48
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.5704
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -18.01
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -59.01
         upper limit
    22.99
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.8389
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -6
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -44.22
         upper limit
    32.21
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1452
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -23.56
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -44.27
         upper limit
    -2.85
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.6399
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -9.61
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -36.03
         upper limit
    16.81
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1949
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -37
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -73.57
         upper limit
    -0.42
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1358
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -47.74
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -88.62
         upper limit
    -6.87
    Statistical analysis title
    Analysis of CDAI Score
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.089
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -50.38
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -88.03
         upper limit
    -12.72

    Secondary: Kaplan-Meier Estimate of the Rate of Time to Relapse

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    End point title
    Kaplan-Meier Estimate of the Rate of Time to Relapse
    End point description
    Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. 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 wellbeing, occurrence of extraintestinal 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 4, 8 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: Percentage of participants
    number (confidence interval 80%)
        Week 4 (n=35,38,38)
    14.58 (8.42 to 22.37)
    7.14 (3.15 to 13.34)
    11.63 (6.3 to 18.73)
        Week 8 (n=32,35,32)
    21.9 (14.27 to 30.6)
    14.47 (8.35 to 22.21)
    23.51 (15.73 to 32.21)
        Week 12 (n=24,30,27)
    39.18 (29.4 to 48.8)
    26.69 (18.32 to 35.77)
    31.09 (22.19 to 40.38)
        Week 20 (n=19,22,23)
    51.85 (41.33 to 61.37)
    39.11 (29.35 to 48.74)
    38.95 (29.16 to 48.6)
        Week 26 (n=1,1,2)
    69.59 (48.73 to 83.29)
    50.69 (38.96 to 61.27)
    43.31 (32.6 to 53.54)
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.44
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -16.14
         upper limit
    1.26
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.43
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -18.27
         upper limit
    3.41
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -12.48
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -25.68
         upper limit
    0.72
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -12.73
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -26.81
         upper limit
    1.34
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -18.9
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -39.52
         upper limit
    1.72
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.96
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -12.39
         upper limit
    6.48
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    1.61
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -10.14
         upper limit
    13.36
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.09
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -21.54
         upper limit
    5.36
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -12.9
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -26.99
         upper limit
    1.19
    Statistical analysis title
    Analysis of Time to Relapse
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -26.28
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -46.54
         upper limit
    -6.02

    Secondary: Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline

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    End point title
    Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
    End point description
    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 wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    12
    11
    15
    Units: Percentage of participants
        number (confidence interval 80%)
    16.67 (4.52 to 38.55)
    27.27 (10.48 to 51.08)
    33.33 (17.2 to 53.17)
    Statistical analysis title
    Analysis of Clinical Remission
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    16.67
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -4.15
         upper limit
    37.49
    Statistical analysis title
    Analysis of Clinical Remission
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    10.61
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -11.44
         upper limit
    32.66

    Secondary: C-Reactive Protein (CRP) by Week

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    End point title
    C-Reactive Protein (CRP) by Week
    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
    Baseline and Weeks 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: milligram per liter (mg/L)
    arithmetic mean (standard deviation)
        Baseline
    8.08 ± 13.88
    7.08 ± 10.83
    8.59 ± 16.43
        Week 4
    16.08 ± 24.62
    8.04 ± 17.36
    7.62 ± 15.03
        Week 8
    15.8 ± 28.98
    8.03 ± 10.86
    7.24 ± 16.48
        Week 12
    15.49 ± 17.8
    8.19 ± 11.75
    5.57 ± 13.52
        Week 20
    15.1 ± 20.37
    10.07 ± 14.56
    6.52 ± 18.26
        Week 26
    27.7 ± 41.76
    13 ± 13.65
    3.57 ± 3.55
    No statistical analyses for this end point

    Secondary: Change from Baseline in CRP by Week

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    End point title
    Change from Baseline in CRP by Week
    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 4, 8, 12, 20 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: milligram per liter (mg/L)
    arithmetic mean (standard deviation)
        Week 4
    10.66 ± 19.47
    0.84 ± 12.52
    -0.97 ± 10.81
        Week 8
    10.33 ± 24.33
    0.96 ± 9.8
    1.29 ± 7.24
        Week 12
    11.78 ± 17.85
    2.36 ± 12.15
    0.39 ± 3.66
        Week 20
    11.48 ± 19.25
    2.92 ± 14.86
    0.91 ± 6.75
        Week 26
    24.07 ± 40.9
    6.62 ± 13.07
    0.59 ± 3.75
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.34
         upper limit
    -0.53
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0024
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.24
         upper limit
    -0.28
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0044
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.26
         upper limit
    -0.24
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0582
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.13
         upper limit
    0.02
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0865
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.31
         upper limit
    0.09
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 4
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.32
         upper limit
    -0.52
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0002
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    -0.45
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.75
         upper limit
    -0.71
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 20
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.87
         upper limit
    -0.74
    Statistical analysis title
    Analysis of CRP
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    -0.95

    Secondary: Fecal Calprotectin by Week

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    End point title
    Fecal Calprotectin by Week
    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
    Baseline and Weeks 8, 12 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: milligrams per kilogram (mg/kg)
    arithmetic mean (standard deviation)
        Baseline
    380.43 ± 296.24
    351.39 ± 290.67
    399.33 ± 346.98
        Week 8
    440.81 ± 350.71
    295.39 ± 272.25
    283.76 ± 304.43
        Week 12
    441.4 ± 336.51
    351.59 ± 303.08
    194 ± 208.5
        Week 26
    939.11 ± 1037.39
    500.18 ± 337.83
    243.76 ± 219.04
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fecal Calprotectin by Week

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    End point title
    Change From Baseline in Fecal Calprotectin by Week
    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 8, 12 and 26
    End point values
    Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    42
    43
    43
    Units: milligrams per kilogram (mg/kg)
    arithmetic mean (standard deviation)
        Week 8
    69.22 ± 384.35
    -59.73 ± 216.36
    -123.95 ± 336.67
        Week 12
    103.55 ± 311.15
    -1.81 ± 228.24
    -107.04 ± 259.68
        Week 26
    579.1 ± 870.77
    154.17 ± 349.49
    -33.75 ± 204.25
    Statistical analysis title
    Analysis of Fecal Calprotectin
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0566
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.79
         upper limit
    0.01
    Statistical analysis title
    Analysis of Fecal Calprotectin
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.3144
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.61
         upper limit
    0.2
    Statistical analysis title
    Analysis of Fecal Calprotectin
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 5 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0434
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    -0.02
    Statistical analysis title
    Analysis of Fecal Calprotectin
    Statistical analysis description
    Week 8
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.005
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.96
         upper limit
    -0.18
    Statistical analysis title
    Analysis of Fecal Calprotectin
    Statistical analysis description
    Week 12
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.0017
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -0.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.06
         upper limit
    -0.25
    Statistical analysis title
    Analysis of Fecal Calprotectin
    Statistical analysis description
    Week 26
    Comparison groups
    Placebo v Tofacitinib 10 mg BID
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Linear mixed-effects model
    Parameter type
    Adjusted Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.72
         upper limit
    -0.67

    Secondary: Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose

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    End point title
    Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose [1]
    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.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit
    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: Inferential analyses were not performed for this endpoint. Only descriptive statistics (mean and standard deviation) for tofacitinib plasma concentration were presented.
    End point values
    Tofacitinib 5 mg BID Tofacitinib 10 mg BID
    Number of subjects analysed
    48
    48
    Units: nanograms per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Week 12, 0 hours (n=43, 40)
    6.059 ± 7.4264
    6.832 ± 5.7271
        Week 12, 20 minutes (n=45, 40)
    31.56 ± 21.904
    58.53 ± 53.579
        Week 12, 40 minutes (n=47, 41)
    47.05 ± 23.904
    85.23 ± 43.726
        Week 12, 1 hour (n=46, 42)
    46.84 ± 20.365
    82.08 ± 33.779
        Week 12, 2 hour (n=44, 42)
    36.52 ± 14.81
    69.79 ± 23.274
        Week 26/ET, 0 hours (n=43, 46)
    6.183 ± 13.673
    9.51 ± 17.115
        Week 26/ET, 20 minutes (n=45, 48)
    40.98 ± 31.713
    60.48 ± 51.084
        Week 26/ET, 40 minutes (n=46, 48)
    55.83 ± 44.421
    85.66 ± 37.983
        Week 26/ET, 1 hour (n=45, 48)
    52.59 ± 42.291
    86.25 ± 30.948
        Week 26/ET, 2 hours (n=44, 48)
    39.09 ± 22.606
    64.15 ± 23.499
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) were assessed from informed consent through and including 28 days after last dose of study treatment (30 weeks). Non-SAEs were recorded from time of first dose of study treatment through last participant visit (30 weeks).
    Adverse event reporting additional description
    The same event may appear as both an adverse event (AE) and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Tofacitinib 5 mg BID
    Reporting group description
    Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.

    Reporting group title
    Tofacitinib 10 mg BID
    Reporting group description
    Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.

    Serious adverse events
    Tofacitinib 5 mg BID Placebo Tofacitinib 10 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 60 (10.00%)
    7 / 59 (11.86%)
    8 / 61 (13.11%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Intestinal anastomosis complication
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn’s disease
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 59 (5.08%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Tofacitinib 5 mg BID Placebo Tofacitinib 10 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 60 (66.67%)
    28 / 59 (47.46%)
    35 / 61 (57.38%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Injury, poisoning and procedural complications
    Tooth fracture
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Blood creatinine increased
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 59 (0.00%)
    5 / 61 (8.20%)
         occurrences all number
    3
    0
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 59 (3.39%)
    2 / 61 (3.28%)
         occurrences all number
    4
    2
    2
    Paraesthesia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    1 / 61 (1.64%)
         occurrences all number
    2
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 59 (3.39%)
    4 / 61 (6.56%)
         occurrences all number
    3
    2
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 60 (8.33%)
    2 / 59 (3.39%)
    4 / 61 (6.56%)
         occurrences all number
    5
    2
    4
    Abdominal tenderness
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    0
    1
    Crohn’s disease
         subjects affected / exposed
    11 / 60 (18.33%)
    10 / 59 (16.95%)
    7 / 61 (11.48%)
         occurrences all number
    11
    11
    10
    Diarrhoea
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 59 (0.00%)
    5 / 61 (8.20%)
         occurrences all number
    3
    0
    5
    Haemorrhoids
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    0
    Dyspepsia
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    2
    3
    1
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 59 (1.69%)
    2 / 61 (3.28%)
         occurrences all number
    1
    1
    2
    Toothache
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Reproductive system and breast disorders
    Endometriosis
    Additional description: Subjects exposed are only females since this AE can only occur in females.
         subjects affected / exposed [1]
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    2 / 61 (3.28%)
         occurrences all number
    0
    1
    2
    Eczema
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences all number
    2
    1
    0
    Rash
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 59 (3.39%)
    0 / 61 (0.00%)
         occurrences all number
    0
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 60 (10.00%)
    2 / 59 (3.39%)
    4 / 61 (6.56%)
         occurrences all number
    6
    2
    5
    Back pain
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    2 / 61 (3.28%)
         occurrences all number
    3
    1
    3
    Torticollis
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Hyperlipidaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    1
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    3
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    0
    0
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    3 / 61 (4.92%)
         occurrences all number
    0
    1
    3
    Gastroenteritis
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    2
    0
    3
    Herpes zoster
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Influenza
         subjects affected / exposed
    5 / 60 (8.33%)
    2 / 59 (3.39%)
    3 / 61 (4.92%)
         occurrences all number
    6
    3
    4
    Oral herpes
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    0 / 61 (0.00%)
         occurrences all number
    1
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    11 / 60 (18.33%)
    4 / 59 (6.78%)
    5 / 61 (8.20%)
         occurrences all number
    11
    4
    5
    Tooth abscess
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 59 (3.39%)
    1 / 61 (1.64%)
         occurrences all number
    1
    2
    2
    Urinary tract infection
         subjects affected / exposed
    6 / 60 (10.00%)
    4 / 59 (6.78%)
    8 / 61 (13.11%)
         occurrences all number
    11
    5
    8
    Vaginal infection
    Additional description: Subjects exposed are only females since this AE can only occur in females.
         subjects affected / exposed [2]
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    Vulvovaginal mycotic infection
    Additional description: Subjects exposed are only females since this AE can only occur in females.
         subjects affected / exposed [3]
    0 / 30 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    1
    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: Male subject are excluded from the total number. Exposed subjects are only females since this AE can only occur in females.
    [2] - 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: Male subject are excluded from the total number. Exposed subjects are only females since this AE can only occur in females.
    [3] - 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: Male subject are excluded from the total number. Exposed subjects are only females since this AE can only occur in females.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2011
    This amendment was produced primarily to correct an error in the first question of the CDAI, the primary endpoint assessment tool, for the study, to add the word “very” before the words “soft stools”. This word was inadvertently omitted in the first version of the protocol. 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 to clarify some language that was felt to be imprecise or unclear in the protocol.
    28 Sep 2012
    This amendment updated standard Pfizer protocol text, including safety language in various sections, including Administration, Reproductive Status of Female Subjects, and Adverse Event Reporting. This amendment also included an updated prohibited medications table, lymphocyte count requirement for participant selection and monitoring and discontinuation criteria for lymphopenia, guidance regarding surgery during the study, and updated to the Background section among other revisions.

    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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