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    Clinical Trial Results:
    A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

    Summary
    EudraCT number
    2007-004157-28
    Trial protocol
    BE   ES   DE   HU   AT   SK   CZ   FR   IT   NL   PT   SE  
    Global end of trial date
    23 Dec 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Dec 2017
    First version publication date
    07 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M10-223
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00573794
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Andreas Lazar, MD, AbbVie, andreas.lazar@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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed Study M06-826 (EudraCT number 2006-002781-20) or Study M06-827 (EudraCT number 2006-002782-40).
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Nov 2007
    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
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Slovakia: 58
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Austria: 17
    Country: Number of subjects enrolled
    Belgium: 27
    Country: Number of subjects enrolled
    Czech Republic: 82
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 41
    Country: Number of subjects enrolled
    Hungary: 38
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Canada: 78
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Switzerland: 9
    Country: Number of subjects enrolled
    United States: 166
    Country: Number of subjects enrolled
    Israel: 3
    Worldwide total number of subjects
    592
    EEA total number of subjects
    322
    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)
    567
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 592 subjects were randomized and received at least 1 dose of study drug (safety population); 7 subjects enrolled at 3 noncompliant sites were excluded from the analyses (Intent-to-treat 1 [ITT-1] population; N=585).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Adalimumab 40 mg EOW/EW
    Arm description
    Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
    Arm type
    Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, HUMIRA
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    adalimumab prefilled syringes administered as subcutaneous injection EW or EOW

    Number of subjects in period 1 [1]
    Adalimumab 40 mg EOW/EW
    Started
    585
    Completed
    255
    Not completed
    330
         Protocol violation
    6
         Adverse event
    81
         Lack of efficacy
    94
         Withdrew consent
    90
         Not Specified
    46
         Lost to follow-up
    13
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: ITT-1 population: All subjects who received ≥1 dose of study drug excluding 7 subjects at noncompliant sites.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab 40 mg EOW/EW
    Reporting group description
    Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

    Reporting group values
    Adalimumab 40 mg EOW/EW Total
    Number of subjects
    585 585
    Age categorical
    Units: Subjects
    Age continuous
    ITT-1 population: All subjects who received ≥1 dose of study drug excluding 7 subjects at noncompliant sites.
    Units: years
        arithmetic mean (standard deviation)
    41.6 ± 12.85 -
    Gender categorical
    ITT-1 population: All subjects who received ≥1 dose of study drug excluding 7 subjects at noncompliant sites.
    Units: Subjects
        Female
    214 214
        Male
    371 371

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab 40 mg EOW/EW
    Reporting group description
    Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

    Primary: Partial Mayo Score: Change From Baseline Over Time

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    End point title
    Partial Mayo Score: Change From Baseline Over Time [1]
    End point description
    The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    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
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    584 [2]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=584)
    2.5 ± 2.02
        Change from Baseline to Week 48 (N=512)
    -0.2 ± 2.04
        Change from Baseline to Week 96 (N=432)
    -0.4 ± 1.78
        Change from Baseline to Week 144 (N=371)
    -0.5 ± 2.06
        Change from Baseline to Week 192 (N=292)
    -0.6 ± 1.84
        Change from Baseline to Week 240 (N=179)
    -0.8 ± 1.79
        Change from Baseline to Week 292 (N=73)
    -0.7 ± 2.05
        Change from Baseline to Week 340 (N=23)
    -1.0 ± 1.97
        Change from Baseline to Week 388 (N=3)
    -2.0 ± 1.00
    Notes
    [2] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Primary: Mayo Score: Change From Baseline Over Time

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    End point title
    Mayo Score: Change From Baseline Over Time [3]
    End point description
    The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.N=number of subjects with evaluable data at given time point.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    Notes
    [3] - 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
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    583 [4]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=583)
    3.5 ± 2.72
        Change from Baseline to Week 48 (N=493)
    -0.3 ± 2.64
        Change from Baseline to Week 96 (N=422)
    -0.5 ± 2.49
        Change from Baseline to Week 144 (N=360)
    -0.8 ± 2.73
        Change from Baseline to Week 192 (N=277)
    -0.8 ± 2.52
        Change from Baseline to Week 240 (N=168)
    -1.0 ± 2.40
        Change from Baseline to Week 292 (N=72)
    -0.9 ± 2.84
        Change from Baseline to Week 340 (N=23)
    -1.3 ± 2.87
        Change from Baseline to Week 388 (N=3)
    -2.0 ± 1.73
    Notes
    [4] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Remission Per Partial Mayo Score Over Time

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    End point title
    Percentage of Participants With Remission Per Partial Mayo Score Over Time
    End point description
    The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore > 1. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    585 [5]
    Units: percentage of participants
    number (not applicable)
        Baseline (N=584)
    52.4
        Change from Baseline to Week 48 (N=513)
    61.2
        Change from Baseline to Week 96 (N=433)
    69.3
        Change from Baseline to Week 144 (N=372)
    75.0
        Change from Baseline to Week 192 (N=293)
    74.7
        Change from Baseline to Week 240 (N=180)
    77.2
        Change from Baseline to Week 292 (N=73)
    76.7
        Change from Baseline to Week 340 (N=23)
    73.9
        Change from Baseline to Week 388 (N=3)
    100
    Notes
    [5] - Participants in ITT-1 population with evaluable data at given timepoint.
    No statistical analyses for this end point

    Secondary: Mayo Endoscopy Subscore: Change From Baseline Over Time

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    End point title
    Mayo Endoscopy Subscore: Change From Baseline Over Time
    End point description
    The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    583 [6]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=583)
    1.1 ± 0.94
        Change from Baseline to Week 48 (N=493)
    -0.1 ± 0.95
        Change from Baseline to Week 96 (N=422)
    -0.1 ± 1.02
        Change from Baseline to Week 144 (N=360)
    -0.2 ± 0.93
        Change from Baseline to Week 192 (N=277)
    -0.3 ± 0.98
        Change from Baseline to Week 240 (N=168)
    -0.3 ± 0.97
        Change from Baseline to Week 292 (N=72)
    -0.3 ± 1.03
        Change from Baseline to Week 340 (N=23)
    -0.3 ± 1.18
        Change from Baseline to Week 388 (N=3)
    0.0 ± 1.00
    Notes
    [6] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Mayo Rectal Bleeding Subscore: Change From Baseline Over Time

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    End point title
    Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
    End point description
    The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    584 [7]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=584)
    0.4 ± 0.68
        Change from Baseline to Week 48 (N=512)
    -0.1 ± 0.73
        Change from Baseline to Week 96 (N=432)
    -0.0 ± 0.63
        Change from Baseline to Week 144 (N=371)
    -0.1 ± 0.74
        Change from Baseline to Week 192 (N=292)
    -0.1 ± 0.69
        Change from Baseline to Week 240 (N=179)
    -0.2 ± 0.63
        Change from Baseline to Week 292 (N=73)
    -0.2 ± 0.76
        Change from Baseline to Week 340 (N=23)
    -0.2 ± 0.80
        Change from Baseline to Week 388 (N=3)
    -1.0 ± 1.00
    Notes
    [7] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time

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    End point title
    Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time
    End point description
    The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    584 [8]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=584)
    0.8 ± 0.81
        Change from Baseline to Week 48 (N=512)
    -0.1 ± 0.89
        Change from Baseline to Week 96 (N=432)
    -0.2 ± 0.84
        Change from Baseline to Week 144 (N=371)
    -0.2 ± 0.89
        Change from Baseline to Week 192 (N=292)
    -0.2 ± 0.82
        Change from Baseline to Week 240 (N=179)
    -0.3 ± 0.82
        Change from Baseline to Week 292 (N=73)
    -0.2 ± 0.79
        Change from Baseline to Week 340 (N=23)
    -0.3 ± 0.88
        Change from Baseline to Week 388 (N=3)
    -0.7 ± 0.58
    Notes
    [8] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Mayo Stool Frequency Subscore: Change From Baseline Over Time

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    End point title
    Mayo Stool Frequency Subscore: Change From Baseline Over Time
    End point description
    The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    584 [9]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=584)
    1.3 ± 1.01
        Change from Baseline to Week 48 (N=512)
    -0.1 ± 0.89
        Change from Baseline to Week 96 (N=432)
    -0.2 ± 0.84
        Change from Baseline to Week 144 (N=371)
    -0.2 ± 0.89
        Change from Baseline to Week 192 (N=292)
    -0.2 ± 0.82
        Change from Baseline to Week 240 (N=179)
    -0.3 ± 0.86
        Change from Baseline to Week 292 (N=73)
    -0.3 ± 1.00
        Change from Baseline to Week 340 (N=23)
    -0.5 ± 0.99
        Change from Baseline to Week 388 (N=3)
    -0.3 ± 0.58
    Notes
    [9] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time

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    End point title
    Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time
    End point description
    The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question 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). N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    572 [10]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=572)
    176.0 ± 34.45
        Change from Baseline to Week 48 (N=485)
    2.1 ± 28.91
        Change from Baseline to Week 96 (N=412)
    4.7 ± 28.73
        Change from Baseline to Week 144 (N=355)
    5.2 ± 30.64
        Change from Baseline to Week 192 (N=279)
    7.6 ± 28.66
        Change from Baseline to Week 240 (N=174)
    11.2 ± 25.98
        Change from Baseline to Week 292 (N=70)
    14.8 ± 27.36
        Change from Baseline to Week 340 (N=23)
    14.6 ± 28.12
        Change from Baseline to Week 388 (N=3)
    11.0 ± 12.53
    Notes
    [10] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time

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    End point title
    36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time
    End point description
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    575 [11]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=575)
    47.1 ± 10.16
        Change from Baseline to Week 48 (N=498)
    -0.7 ± 9.61
        Change from Baseline to Week 96 (N=423)
    0.3 ± 9.64
        Change from Baseline to Week 144 (N=360)
    0.0 ± 9.52
        Change from Baseline to Week 192 (N=286)
    0.1 ± 9.41
        Change from Baseline to Week 240 (N=178)
    0.7 ± 7.86
        Change from Baseline to Week 292 (N=71)
    1.8 ± 8.13
        Change from Baseline to Week 340 (N=23)
    1.8 ± 6.81
        Change from Baseline to Week 388 (N=3)
    -7.3 ± 5.58
    Notes
    [11] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time

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    End point title
    36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time
    End point description
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    575 [12]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N=575)
    49.3 ± 8.06
        Change from Baseline to Week 48 (N=498)
    0.7 ± 6.98
        Change from Baseline to Week 96 (N=423)
    1.2 ± 6.26
        Change from Baseline to Week 144 (N=360)
    1.1 ± 7.08
        Change from Baseline to Week 192 (N=286)
    1.3 ± 7.46
        Change from Baseline to Week 240 (N=178)
    2.2 ± 6.23
        Change from Baseline to Week 292 (N=71)
    2.5 ± 7.03
        Change from Baseline to Week 340 (N=23)
    3.0 ± 8.71
        Change from Baseline to Week 388 (N=3)
    8.4 ± 2.00
    Notes
    [12] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time

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    End point title
    Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time
    End point description
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    375 [13]
    Units: percent of work time missed
    arithmetic mean (standard deviation)
        Baseline (N=375)
    4.5 ± 15.42
        Change from Baseline to Week 48 (N=294)
    1.6 ± 24.04
        Change from Baseline to Week 96 (N=245)
    -0.2 ± 18.41
        Change from Baseline to Week 144 (N=213)
    0.9 ± 20.19
        Change from Baseline to Week 192 (N=170)
    0.2 ± 19.05
        Change from Baseline to Week 240 (N=109)
    -1.1 ± 17.21
        Change from Baseline to Week 292 (N=47)
    8.2 ± 30.65
        Change from Baseline to Week 340 (N=16)
    6.4 ± 24.96
        Change from Baseline to Week 388 (N=2)
    0.0 ± 0.00
    Notes
    [13] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: WPAI:GH Impairment While Working: Change From Baseline Over Time

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    End point title
    WPAI:GH Impairment While Working: Change From Baseline Over Time
    End point description
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    388 [14]
    Units: percent of work time impaired
    arithmetic mean (standard deviation)
        Baseline (N=388)
    16.7 ± 20.73
        Change from Baseline to Week 48 (N=315)
    1.1 ± 22.45
        Change from Baseline to Week 96 (N=262)
    -1.9 ± 20.86
        Change from Baseline to Week 144 (N=233)
    -0.2 ± 24.11
        Change from Baseline to Week 192 (N=177)
    -2.9 ± 24.04
        Change from Baseline to Week 240 (N=119)
    -4.0 ± 21.40
        Change from Baseline to Week 292 (N=52)
    -3.8 ± 25.45
        Change from Baseline to Week 340 (N=16)
    -13.8 ± 26.04
        Change from Baseline to Week 388 (N=2)
    -15.0 ± 21.21
    Notes
    [14] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: WPAI:GH Overall Work Impairment: Change From Baseline Over Time

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    End point title
    WPAI:GH Overall Work Impairment: Change From Baseline Over Time
    End point description
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    373 [15]
    Units: percent of overall work impairment
    arithmetic mean (standard deviation)
        Baseline (N=373)
    20.1 ± 24.30
        Change from Baseline to Week 48 (N=294)
    1.2 ± 28.15
        Change from Baseline to Week 96 (N=244)
    -2.7 ± 24.99
        Change from Baseline to Week 144 (N=212)
    -0.8 ± 28.05
        Change from Baseline to Week 192 (N=168)
    -2.6 ± 26.69
        Change from Baseline to Week 240 (N=109)
    -5.0 ± 24.1
        Change from Baseline to Week 292 (N=47)
    1.4 ± 35.53
        Change from Baseline to Week 340 (N=16)
    -7.3 ± 12.05
        Change from Baseline to Week 388 (N=2)
    -15.0 ± 21.21
    Notes
    [15] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: WPAI:GH Activity Impairment: Change From Baseline Over Time

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    End point title
    WPAI:GH Activity Impairment: Change From Baseline Over Time
    End point description
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    550 [16]
    Units: percent activity impaired
    arithmetic mean (standard deviation)
        Baseline (N=550)
    21.4 ± 24.00
        Change from Baseline to Week 48 (N=479)
    1.1 ± 24.14
        Change from Baseline to Week 96 (N=405)
    -1.6 ± 21.80
        Change from Baseline to Week 144 (N=351)
    -0.7 ± 23.65
        Change from Baseline to Week 192 (N=267)
    -2.1 ± 20.91
        Change from Baseline to Week 240 (N=171)
    -3.4 ± 18.63
        Change from Baseline to Week 292 (N=68)
    -1.5 ± 19.79
        Change from Baseline to Week 340 (N=23)
    -9.6 ± 11.86
        Change from Baseline to Week 388 (N=3)
    -16.7 ± 15.28
    Notes
    [16] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Colectomy Rate

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    End point title
    Colectomy Rate
    End point description
    The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    585 [17]
    Units: percentage of participants
        number (not applicable)
    3.88
    Notes
    [17] - ITT-1 population
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations

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    End point title
    Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
    End point description
    The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented.
    End point type
    Secondary
    End point timeframe
    5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    585 [18]
    Units: cumulative number of utilizations
    number (not applicable)
        Physician
    561
        Emergency Room
    43
        Hospital Admission
    65
        Days in Hospital
    435
    Notes
    [18] - ITT-1 population
    No statistical analyses for this end point

    Secondary: Hematology: Mean Change From Baseline to Final Values in Hemoglobin

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    End point title
    Hematology: Mean Change From Baseline to Final Values in Hemoglobin
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    575 [19]
    Units: g/L
        arithmetic mean (standard deviation)
    -0.1 ± 16.02
    Notes
    [19] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Hematology: Mean Change From Baseline to Final Values in Hematocrit

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    End point title
    Hematology: Mean Change From Baseline to Final Values in Hematocrit
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    575 [20]
    Units: Percentage of red blood cells
        arithmetic mean (standard deviation)
    0.013 ± 0.0472
    Notes
    [20] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils

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    End point title
    Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    575 [21]
    Units: cells x 100^9/L
    arithmetic mean (standard deviation)
        Red blood cell count (N=575)
    0.03 ± 0.416
        Platelet count (N=572)
    -10.5 ± 96.98
        White blood cell count (N=575)
    0.41 ± 2.704
        Neutrophils (N=572)
    0.164 ± 2.4225
        Lymphocytes (N=572)
    0.155 ± 0.8270
        Monocytes (N=572)
    0.051 ± 0.2203
        Eosinophils (N=572)
    0.002 ± 0.1602
        Basophils (N=572)
    0.009 ± 0.0586
    Notes
    [21] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase

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    End point title
    Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    581 [22]
    Units: U/L
    arithmetic mean (standard deviation)
        Alanine aminotransferase (N=579)
    3.7 ± 22.03
        Aspartate aminotransferase (N=579)
    2.6 ± 28.13
        Alkaline phosphatase (N=581)
    -0.2 ± 34.65
    Notes
    [22] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid

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    End point title
    Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    581 [23]
    Units: μmol/L
    arithmetic mean (standard deviation)
        Total bilirubin
    -1.0 ± 5.35
        Creatinine
    2.4 ± 13.18
        Uric acid
    7.6 ± 65.52
    Notes
    [23] - Participants in ITT-1 population with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides

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    End point title
    Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    581 [24]
    Units: mmol/L
    arithmetic mean (standard deviation)
        Blood urea nitrogen
    0.32 ± 1.409
        Inorganic phosphate
    -0.003 ± 0.2312
        Calcium
    -0.012 ± 0.1185
        Sodium
    -0.0 ± 2.49
        Potassium
    0.07 ± 0.424
        Glucose
    0.05 ± 1.334
        Cholesterol
    -0.025 ± 0.8853
        Triglycerides
    0.178 ± 1.2800
    Notes
    [24] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein

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    End point title
    Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    581 [25]
    Units: g/L
    arithmetic mean (standard deviation)
        Albumin
    -0.4 ± 3.85
        Total protein
    0.7 ± 18.99
    Notes
    [25] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Secondary: Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein

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    End point title
    Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein
    End point description
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
    End point type
    Secondary
    End point timeframe
    Up to 5 years
    End point values
    Adalimumab 40 mg EOW/EW
    Number of subjects analysed
    575 [26]
    Units: mg/L
        arithmetic mean (standard deviation)
    0.382 ± 15.1489
    Notes
    [26] - Participants in the safety analysis set with both Baseline and visit values.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks).
    Adverse event reporting additional description
    TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Adalimumab 40 mg EOW/EW
    Reporting group description
    Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.

    Serious adverse events
    Adalimumab 40 mg EOW/EW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    158 / 592 (26.69%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhagic infarction
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    3 / 592 (0.51%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cervix carcinoma stage 0
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    3 / 592 (0.51%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Drug intolerance
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysplasia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multimorbidity
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic behaviour
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostatism
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Uterine cyst
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    False positive tuberculosis test
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Aortic valve stenosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Cardiogenic shock
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tachycardia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Allergic respiratory symptom
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nasal obstruction
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 592 (1.01%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Demyelination
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 592 (0.51%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    34 / 592 (5.74%)
         occurrences causally related to treatment / all
    2 / 39
         deaths causally related to treatment / all
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal dysplasia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pseudopolyposis
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Rectal perforation
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Portal hypertension
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema multiforme
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erythema nodosum
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    3 / 592 (0.51%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lupus-like syndrome
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    5 / 592 (0.84%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sympathetic posterior cervical syndrome
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Adrenal haemorrhage
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Abscess of salivary gland
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal abscess
         subjects affected / exposed
    3 / 592 (0.51%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 592 (0.84%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile immunisation
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster meningitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Injection site abscess
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injection site cellulitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    11 / 592 (1.86%)
         occurrences causally related to treatment / all
    10 / 13
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    2 / 592 (0.34%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 592 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adalimumab 40 mg EOW/EW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    391 / 592 (66.05%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    37 / 592 (6.25%)
         occurrences all number
    41
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    41 / 592 (6.93%)
         occurrences all number
    46
    Oropharyngeal pain
         subjects affected / exposed
    33 / 592 (5.57%)
         occurrences all number
    36
    Nervous system disorders
    Headache
         subjects affected / exposed
    46 / 592 (7.77%)
         occurrences all number
    66
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    35 / 592 (5.91%)
         occurrences all number
    40
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    38 / 592 (6.42%)
         occurrences all number
    52
    Colitis ulcerative
         subjects affected / exposed
    180 / 592 (30.41%)
         occurrences all number
    279
    Diarrhoea
         subjects affected / exposed
    46 / 592 (7.77%)
         occurrences all number
    62
    Nausea
         subjects affected / exposed
    34 / 592 (5.74%)
         occurrences all number
    41
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    42 / 592 (7.09%)
         occurrences all number
    47
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    62 / 592 (10.47%)
         occurrences all number
    88
    Back pain
         subjects affected / exposed
    40 / 592 (6.76%)
         occurrences all number
    51
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    40 / 592 (6.76%)
         occurrences all number
    53
    Influenza
         subjects affected / exposed
    42 / 592 (7.09%)
         occurrences all number
    50
    Sinusitis
         subjects affected / exposed
    53 / 592 (8.95%)
         occurrences all number
    81
    Upper respiratory tract infection
         subjects affected / exposed
    58 / 592 (9.80%)
         occurrences all number
    91
    Viral upper respiratory tract infection
         subjects affected / exposed
    115 / 592 (19.43%)
         occurrences all number
    198

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Nov 2011
    The main purpose of this amendment was to add regular tuberculosis (TB) testing and to add language regarding physical examination to align with physicians' usual clinical practice methods.
    14 Mar 2012
    The main purpose of this amendment was to allow the option of dose de-escalation by reducing dose frequency; add blood sample collections for adalimumab concentration and anti-adalimumab antibody (AAA) assays to be used for long-term PK data; add local laboratory use if QuantiFERON-TB Gold test or equivalent is used; and extended the duration of the study to 292 weeks
    17 Dec 2013
    The main purpose of this amendment was to extend the duration of the study to 388 weeks; include additional anti-tumor necrosis factor (anti-TNF) information; and clarify chest x-ray, pregnancy information, toxicity management, and protocol deviations.

    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.
    Efficacy data after Week 292 should be interpreted with caution because less than 10% of subjects were under observation beyond Week 292.
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