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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2014-004559-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Aug 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 May 2016
    First version publication date
    24 Jun 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    potential timestamp issues

    Trial information

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    Trial identification
    Sponsor protocol code
    M10-447
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00853099
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Morio Ozawa, AbbVie, morio.ozawa@abbvie.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC). Patients are randomized 1:1:1 to receive subcutaneous injections of adalimumab at either 160/80 mg at Week 0/2 and 40 mg every other week (eow) starting at Week 4 to Week 50, 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or placebo eow starting at Week 0 to Week 50 under the double-blind condition. At or after Week 8, participants who have inadequate response during the double-blind period can switch to the rescue arm, where participants from the placebo group initially receive adalimumab 160 mg and 80 mg 2 weeks later and those from the adalimumab group receive adalimumab 40 mg initially and 2 weeks later under double-blind conditions. All participants in the rescue arm then receive 40 mg adalimumab eow until Week 50. Seven participants randomized to placebo did not receive any adalimumab.
    Protection of trial subjects
    Participant and/or legal guardian (if subject < 20 years of age) read and understood information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 274
    Worldwide total number of subjects
    274
    EEA total number of subjects
    0
    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)
    4
    Adults (18-64 years)
    249
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a screening period of 21 days.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Double-blind Placebo
    Arm description
    		 Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
    Arm type
    		 Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira, D2E7
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab administered by subcutaneous injection as rescue medication

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for adalimumab administered by subcutaneous injection

    Arm title
    		 Double-blind Adalimumab 80 mg/40 mg
    Arm description
    		 Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
    Arm type
    		 Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira, D2E7
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab administered by subcutaneous injection

    Arm title
    		 Double-blind Adalimumab 160 mg/80 mg
    Arm description
    		 Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira, D2E7
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab administered by subcutaneous injection

    Number of subjects in period 1
    		Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Started
    96
    87
    90
    Treated
    96
    87
    90
    Completed Week 8
    92
    85
    86
    Completed
    73
    58
    60
    Not completed
    23
    29
    30
         Consent withdrawn by subject
    2
    3
    -
         Not Specified
    -
    -
    1
         Adverse event
    7
    9
    13
         Lack of efficacy
    14
    17
    16
    Period 2
    Period 2 title
    Double-blind + Open-label Periods
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 All Adalimumab
    Arm description
    		 All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira, D2E7
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab administered by subcutaneous injection

    Number of subjects in period 2
    		All Adalimumab
    Started
    266
    Completed
    119
    Not completed
    147
         Consent withdrawn by subject
    20
         Not Specified
    6
         Adverse event
    47
         Lack of efficacy
    74

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Double-blind Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

    Reporting group title
    Double-blind Adalimumab 80 mg/40 mg
    Reporting group description
    		 Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

    Reporting group title
    Double-blind Adalimumab 160 mg/80 mg
    Reporting group description
    		 Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant, incorrectly treated with open-label (rescue) study drug at Week 0, was excluded.
    Reporting group values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg Total
    Number of subjects
    		 96 87 90
    Age categorical
    Units: Subjects
    Age Continuous
    Demographic data are provided for the Full Analysis Set (FAS), which includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication.
    Units: years
        arithmetic mean (standard deviation)
    		 41.3 ( 13.56 ) 44.4 ( 15.04 ) 42.5 ( 14.56 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 26 37 29 92
        Male
    		 70 50 61 181
    Mayo score
    A composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores: Stool frequency, based on the participant's diary, scored from 0 (normal number of stools) to 3 (≥5 stools than normal); Rectal bleeding, based on the participant's diary, scored from 0 (no blood) to 3 (blood only passed); Endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); and Physician's Global Assessment, scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12; higher scores indicate more severe disease.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    		 8.5 ( 1.56 ) 8.5 ( 1.42 ) 8.6 ( 1.44 ) -

    End points

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    End points reporting groups
    Reporting group title
    Double-blind Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

    Reporting group title
    Double-blind Adalimumab 80 mg/40 mg
    Reporting group description
    		 Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

    Reporting group title
    Double-blind Adalimumab 160 mg/80 mg
    Reporting group description
    		 Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
    Reporting group title
    All Adalimumab
    Reporting group description
    		 All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).

    Primary: Percentage of Participants With Clinical Remission at 8 Weeks

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    End point title
    		 Percentage of Participants With Clinical Remission at 8 Weeks [1]
    End point description
    Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of UC disease activity calculated as the sum of 4 subscores: •Stool Frequency Subscore (SFS), based on the participant's diary, scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore (RBS), based on the participant's diary, scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy , scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); •Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12; higher scores representing more severe disease. FAS; non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96
    87
    90
    Units: percentage of participants
        number (not applicable)
    11.5
    13.8
    10
    No statistical analyses for this end point

    Primary: Percentage of Participants With Clinical Remission at 52 Weeks

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    End point title
    		 Percentage of Participants With Clinical Remission at 52 Weeks [2]
    End point description
    Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores: Stool Frequency Subscore (SFS), based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); •Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.
    End point type
    Primary
    End point timeframe
    Week 52
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [3]
    87 [4]
    90 [5]
    Units: percentage of participants
        number (not applicable)
    7.3
    26.4
    20
    Notes
    [3] - FAS; NRI was used
    [4] - FAS; NRI was used
    [5] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks

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    End point title
    		 Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks
    End point description
    Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores: •Stool Frequency Subscore (SFS), based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);•Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [6]
    87 [7]
    90 [8]
    Units: percentage of participants
    number (not applicable)
        Week 8
    11.5
    13.8
    10
        Week 32
    8.3
    17.2
    17.8
        Week 52
    7.3
    26.4
    20
    Notes
    [6] - FAS; NRI was used
    [7] - FAS; NRI was used
    [8] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Clinical Response

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    End point title
    		 Percentage of Participants With a Clinical Response
    End point description
    A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores: •Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); •Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); •Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); •Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [9]
    87 [10]
    90 [11]
    Units: percentage of participants
    number (not applicable)
        Week 8
    35.4
    42.5
    50
        Week 32
    20.8
    33.3
    37.8
        Week 52
    17.7
    29.9
    31.1
    Notes
    [9] - FAS; NRI was used
    [10] - FAS; NRI was used
    [11] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Mucosal Healing

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    End point title
    		 Percentage of Participants with Mucosal Healing
    End point description
    Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52. The endoscopy subscore ranges from zero to three as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration).
    End point type
    Secondary
    End point timeframe
    Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [12]
    87 [13]
    90 [14]
    Units: percentage of participants
    number (not applicable)
        Week 8
    30.2
    39.1
    44.4
        Week 32
    21.9
    27.6
    31.1
        Week 52
    15.6
    28.7
    28.9
    Notes
    [12] - FAS; NRI was used
    [13] - FAS; NRI was used
    [14] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)

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    End point title
    		 Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
    End point description
    Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from 0 to 3, according to the following scale: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [15]
    87 [16]
    90 [17]
    Units: percentage of participants
    number (not applicable)
        Week 8
    67.7
    80.5
    71.1
        Week 32
    28.1
    40.2
    43.3
        Week 52
    22.9
    32.2
    34.4
    Notes
    [15] - FAS; NRI was used
    [16] - FAS; NRI was used
    [17] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)

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    End point title
    		 Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
    End point description
    The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0 to 3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).
    End point type
    Secondary
    End point timeframe
    Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [18]
    87 [19]
    90 [20]
    Units: percentage of participants
    number (not applicable)
        Week 8
    44.8
    47.1
    61.1
        Week 32
    28.1
    36.8
    37.8
        Week 52
    19.8
    29.9
    34.4
    Notes
    [18] - FAS; NRI was used
    [19] - FAS; NRI was used
    [20] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)

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    End point title
    		 Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
    End point description
    Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from 0 to 3, according to the following scale: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [21]
    87 [22]
    90 [23]
    Units: percentage of participants
    number (not applicable)
        Week 8
    32.3
    34.5
    40
        Week 32
    20.8
    33.3
    31.1
        Week 52
    13.5
    28.7
    28.9
    Notes
    [21] - FAS; NRI was used
    [22] - FAS; NRI was used
    [23] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders

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    End point title
    		 Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
    End point description
    An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 32, and 52
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [24]
    87 [25]
    90 [26]
    Units: percentage of participants
    number (not applicable)
        Week 8
    39.6
    48.3
    42.2
        Week 32
    21.9
    33.3
    28.9
        Week 52
    12.5
    29.9
    21.1
    Notes
    [24] - FAS; NRI was used
    [25] - FAS; NRI was used
    [26] - FAS; NRI was used
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events up to Week 8

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    End point title
    		 Number of Participants With Adverse Events up to Week 8
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [27]
    87 [28]
    90 [29]
    Units: participants
    number (not applicable)
        Any adverse event
    45
    49
    40
        Any AE at least possibly drug related
    10
    14
    12
        Any serious adverse event
    7
    2
    4
        Any AE leading to discontinuation of study drug
    4
    0
    6
    Notes
    [27] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    [28] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    [29] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events up to Week 52

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    End point title
    		 Number of Participants With Adverse Events up to Week 52
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
    End point type
    Secondary
    End point timeframe
    52 weeks
    End point values
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg
    Number of subjects analysed
    96 [30]
    87 [31]
    90 [32]
    Units: participants
    number (not applicable)
        Any adverse event
    67
    68
    75
        Any AE at least possibly drug related
    17
    23
    32
        Any serious adverse event
    12
    14
    10
        Any AE leading to discontinuation of study drug
    5
    5
    12
    Notes
    [30] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    [31] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    [32] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events During the Adalimumab Treatment Period

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    End point title
    		 Number of Participants With Adverse Events During the Adalimumab Treatment Period
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
    End point type
    Secondary
    End point timeframe
    221 weeks
    End point values
    		 All Adalimumab
    Number of subjects analysed
    266 [33]
    Units: participants
    number (not applicable)
        Any adverse event
    261
        Any AE at least possibly drug related
    142
        Any serious adverse event
    90
        Any AE leading to discontinuation of study drug
    37
    Notes
    [33] - The Safety Analysis Set includes all participants who received at least one dose of study medication
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug.
    Adverse event reporting additional description
    Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Double-blind Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.

    Reporting group title
    Double-blind Adalimumab 80 mg/40 mg
    Reporting group description
    		 Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.

    Reporting group title
    Double-blind Adalimumab 160 mg/80 mg
    Reporting group description
    		 Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.

    Reporting group title
    All Adalimumab
    Reporting group description
    		 All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).

    Serious adverse events
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 96 (13.54%)
    14 / 87 (16.09%)
    10 / 90 (11.11%)
    90 / 266 (33.83%)
         number of deaths (all causes)
    0
    0
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    3 / 266 (1.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Takayasu's arteritis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Immunosuppressant drug therapy
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Fatigue
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Drug level
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical observation
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    3 / 266 (1.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heat illness
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    0 / 266 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    8 / 96 (8.33%)
    5 / 87 (5.75%)
    5 / 90 (5.56%)
    38 / 266 (14.29%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 5
    2 / 40
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic polyp
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    3 / 266 (1.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal dysplasia
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    3 / 266 (1.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal stenosis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal ulcer haemorrhage
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    0 / 266 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema nodosum
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    0 / 266 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    1 / 90 (1.11%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gingivitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    1 / 90 (1.11%)
    3 / 266 (1.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    1 / 266 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    0 / 266 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 87 (0.00%)
    0 / 90 (0.00%)
    2 / 266 (0.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 96 (53.13%)
    47 / 87 (54.02%)
    60 / 90 (66.67%)
    235 / 266 (88.35%)
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 87 (3.45%)
    6 / 90 (6.67%)
    22 / 266 (8.27%)
         occurrences all number
    2
    3
    8
    30
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 87 (1.15%)
    1 / 90 (1.11%)
    15 / 266 (5.64%)
         occurrences all number
    2
    1
    1
    15
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 96 (6.25%)
    3 / 87 (3.45%)
    7 / 90 (7.78%)
    42 / 266 (15.79%)
         occurrences all number
    9
    3
    7
    62
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    7 / 96 (7.29%)
    4 / 87 (4.60%)
    8 / 90 (8.89%)
    24 / 266 (9.02%)
         occurrences all number
    7
    4
    8
    29
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 87 (3.45%)
    7 / 90 (7.78%)
    13 / 266 (4.89%)
         occurrences all number
    0
    3
    7
    13
    Injection site reaction
         subjects affected / exposed
    2 / 96 (2.08%)
    7 / 87 (8.05%)
    6 / 90 (6.67%)
    25 / 266 (9.40%)
         occurrences all number
    2
    7
    7
    29
    Pyrexia
         subjects affected / exposed
    4 / 96 (4.17%)
    4 / 87 (4.60%)
    5 / 90 (5.56%)
    24 / 266 (9.02%)
         occurrences all number
    4
    4
    5
    28
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    5 / 96 (5.21%)
    2 / 87 (2.30%)
    5 / 90 (5.56%)
    20 / 266 (7.52%)
         occurrences all number
    6
    2
    6
    20
    Dental caries
         subjects affected / exposed
    5 / 96 (5.21%)
    6 / 87 (6.90%)
    3 / 90 (3.33%)
    27 / 266 (10.15%)
         occurrences all number
    5
    6
    3
    28
    Nausea
         subjects affected / exposed
    4 / 96 (4.17%)
    2 / 87 (2.30%)
    5 / 90 (5.56%)
    26 / 266 (9.77%)
         occurrences all number
    5
    2
    6
    32
    Stomatitis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    1 / 90 (1.11%)
    14 / 266 (5.26%)
         occurrences all number
    1
    0
    1
    18
    Vomiting
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    4 / 90 (4.44%)
    23 / 266 (8.65%)
         occurrences all number
    1
    0
    4
    26
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    1 / 90 (1.11%)
    14 / 266 (5.26%)
         occurrences all number
    0
    1
    1
    16
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 96 (2.08%)
    0 / 87 (0.00%)
    2 / 90 (2.22%)
    23 / 266 (8.65%)
         occurrences all number
    2
    0
    2
    30
    Upper respiratory tract inflammation
         subjects affected / exposed
    4 / 96 (4.17%)
    3 / 87 (3.45%)
    5 / 90 (5.56%)
    27 / 266 (10.15%)
         occurrences all number
    5
    4
    6
    55
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 96 (2.08%)
    4 / 87 (4.60%)
    1 / 90 (1.11%)
    27 / 266 (10.15%)
         occurrences all number
    2
    4
    1
    33
    Rash
         subjects affected / exposed
    5 / 96 (5.21%)
    4 / 87 (4.60%)
    3 / 90 (3.33%)
    27 / 266 (10.15%)
         occurrences all number
    5
    5
    3
    30
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 87 (2.30%)
    3 / 90 (3.33%)
    23 / 266 (8.65%)
         occurrences all number
    2
    2
    3
    23
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 96 (3.13%)
    3 / 87 (3.45%)
    4 / 90 (4.44%)
    31 / 266 (11.65%)
         occurrences all number
    3
    3
    4
    34
    Arthralgia
         subjects affected / exposed
    1 / 96 (1.04%)
    5 / 87 (5.75%)
    2 / 90 (2.22%)
    21 / 266 (7.89%)
         occurrences all number
    1
    6
    2
    25
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 87 (0.00%)
    2 / 90 (2.22%)
    16 / 266 (6.02%)
         occurrences all number
    1
    0
    2
    16
    Influenza
         subjects affected / exposed
    6 / 96 (6.25%)
    3 / 87 (3.45%)
    4 / 90 (4.44%)
    20 / 266 (7.52%)
         occurrences all number
    6
    3
    4
    22
    Nasopharyngitis
         subjects affected / exposed
    21 / 96 (21.88%)
    19 / 87 (21.84%)
    30 / 90 (33.33%)
    162 / 266 (60.90%)
         occurrences all number
    38
    29
    44
    463
    Oral herpes
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 87 (1.15%)
    0 / 90 (0.00%)
    14 / 266 (5.26%)
         occurrences all number
    0
    1
    0
    14
    Pharyngitis
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 87 (1.15%)
    1 / 90 (1.11%)
    15 / 266 (5.64%)
         occurrences all number
    2
    1
    1
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2009
    Clarified the concomitant usage of corticosteroids. Description change for protocol deviation due to the revision of GCP.
    10 May 2011
    Added the procedure to collecting Mayo score and partial Mayo score information for 5 days (from 5 days to 1 day before the evaluation date).
    12 Apr 2012
    Added tuberculosis text in the procedure on or after Week 52.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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