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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2014-004531-39
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Nov 2010

    Results information
    Results version number
    v2(current)
    This version publication date
    17 Jun 2016
    First version publication date
    13 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
    M06-837
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00445432
    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
    Global Medical Information, AbbVie, 001 800-633-9110,
    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
    26 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease (CD).
    Protection of trial subjects
    Prior to any study-related screening procedures being performed on the subject, the informed consent statement was reviewed and signed and dated by the subject and/or parent or legal guardian (if the subject was < 20 years old) and the person who administered the informed consent. If clinical trial support staff gave additional explanations, he/she also signed and date the informed consent statement.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Mar 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 83
    Worldwide total number of subjects
    83
    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)
    2
    Adults (18-64 years)
    81
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    All participants who completed lead-in adalimumab induction therapy study (M04-729 [NCT00445939]) were eligible.

    Pre-assignment
    Screening details
    Participants who rolled over into this study received either double-blind (DB) treatment (adalimumab or placebo; responders (decrease in Crohn's Disease Activity Index [CDAI] ≥70 points from lead-in baseline score [CR-70 response] by Week 4 of M14-729) or open-label (OL) treatment (adalimumab; non-responders by Week 4 of M14-729).

    Period 1
    Period 1 title
    Through Week 52 of NCT00445432 (M06-837)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Participants who had CR-70 response at Week 4 of the induction study (study M04-729 [NCT00445939]) were randomized into 1 of 2 treatment groups (DB adalimumab 40 mg every other week or DB adalimumab placebo every other week) using 2 stratification factors - CDAI category (CDAI less than 150 and CDAI 150 or higher) and presence/absence of fistula at Week 0 of this study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    DB Adalimumab 40 mg Eow
    Arm description
    Double-blind 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
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)

    Arm title
    OL Adalimumab 40 mg Eow
    Arm description
    Open-label adalimumab 40 mg every other week (eow)
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira, D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)

    Arm title
    DB Placebo Eow
    Arm description
    Double-blind adalimumab placebo every other week (eow)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    placebo
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)

    Number of subjects in period 1 [1]
    DB Adalimumab 40 mg Eow OL Adalimumab 40 mg Eow DB Placebo Eow
    Started
    25
    32
    25
    Completed
    10
    21
    2
    Not completed
    15
    11
    23
         Moved to open-label
    14
    -
    20
         Adverse event
    1
    7
    2
         Not specified
    -
    2
    1
         Consent withdrawn by subject
    -
    2
    -
    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: Any Adalimumab includes all subjects who had at least one dose of adalimumab during study M06-837: 32 subjects were randomized to receive OL adalimumab, 25 subjects were randomized to DB adalimumab, and 24 subjects were randomized to receive DB placebo and switched to OL adalimumab (3 subjects discontinued while receiving DB placebo and never received any adalimumab).
    Period 2
    Period 2 title
    148 Weeks of Adalimumab Treatment
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Any Adalimumab
    Arm description
    All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira, D2E7
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)

    Number of subjects in period 2 [2]
    Any Adalimumab
    Started
    32
    Completed
    35
    Not completed
    44
         Adverse event
    32
         Not specified
    9
         Consent withdrawn by subject
    3
    Joined
    47
         Randomized to DB placebo-switched to OL adalimumab
    22
         Randomized to DB adalimumab
    25
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One subject was randomized but did not receive study drug; the subject was excluded from efficacy analyses.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DB Adalimumab 40 mg Eow
    Reporting group description
    Double-blind adalimumab 40 mg every other week

    Reporting group title
    OL Adalimumab 40 mg Eow
    Reporting group description
    Open-label adalimumab 40 mg every other week (eow)

    Reporting group title
    DB Placebo Eow
    Reporting group description
    Double-blind adalimumab placebo every other week (eow)

    Reporting group values
    DB Adalimumab 40 mg Eow OL Adalimumab 40 mg Eow DB Placebo Eow Total
    Number of subjects
    25 32 25 82
    Age categorical
    Units: Subjects
        <=18 years
    0 3 2 5
        Between 18 and 65 years
    25 29 23 77
        >=65 years
    0 0 0 0
    Age continuous
    Units:
        
    31.6 ± 7.171 30.75 ± 8.359 30.8 ± 10.939 -
    Gender categorical
    Units: Subjects
        Female
    9 14 10 33
        Male
    16 18 15 49

    End points

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    End points reporting groups
    Reporting group title
    DB Adalimumab 40 mg Eow
    Reporting group description
    Double-blind adalimumab 40 mg every other week

    Reporting group title
    OL Adalimumab 40 mg Eow
    Reporting group description
    Open-label adalimumab 40 mg every other week (eow)

    Reporting group title
    DB Placebo Eow
    Reporting group description
    Double-blind adalimumab placebo every other week (eow)
    Reporting group title
    Any Adalimumab
    Reporting group description
    All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).

    Primary: Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment

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    End point title
    Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment [1] [2]
    End point description
    Clinical remission=Crohn's Disease Activity Index (CDAI) < 150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement. Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.
    End point type
    Primary
    End point timeframe
    Week 52 of double-blind treatment
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary efficacy end point was assessed only in subjects receiving double-blind treatment.
    End point values
    DB Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    21
    22
    Units: Participants
        number (not applicable)
    8
    2
    No statistical analyses for this end point

    Secondary: Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment

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    End point title
    Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
    End point description
    Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab [not placebo] during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-70 not achieved) used for DB treatments; last observation carried forward (LOCF) for OL treatment.
    End point type
    Secondary
    End point timeframe
    Week 52 of double-blind treatment
    End point values
    DB Adalimumab 40 mg Eow OL Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    21
    32
    22
    Units: Participants
        number (not applicable)
    9
    10
    2
    No statistical analyses for this end point

    Secondary: Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment

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    End point title
    Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment
    End point description
    Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.
    End point type
    Secondary
    End point timeframe
    Week 52 of double-blind treatment
    End point values
    DB Adalimumab 40 mg Eow OL Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    21
    32
    22
    Units: Participants
        number (not applicable)
    8
    8
    2
    No statistical analyses for this end point

    Secondary: Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

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    End point title
    Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment [3]
    End point description
    Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. LOCF used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary efficacy end point was assessed only in subjects receiving double-blind treatment.
    End point values
    DB Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    21
    22
    Units: units on a scale
        arithmetic mean (standard deviation)
    -83.7 ± 110.26
    -9.1 ± 110.41
    No statistical analyses for this end point

    Secondary: Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment

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    End point title
    Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment [4]
    End point description
    Clinical remission=Crohn's Disease Activity Index (CDAI) < 150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug). LOCF used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 52 of open-label treatment
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Primary efficacy end point was assessed in subjects receiving double-blind treatment.
    End point values
    OL Adalimumab 40 mg Eow
    Number of subjects analysed
    32
    Units: Participants
        number (not applicable)
    5
    No statistical analyses for this end point

    Secondary: Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

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    End point title
    Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment [5]
    End point description
    The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease. Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. LOCF used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary efficacy end point was assessed only in subjects receiving double-blind treatment.
    End point values
    DB Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    21
    22
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.8 ± 1.89
    -0.2 ± 1.34
    No statistical analyses for this end point

    Secondary: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

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    End point title
    Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment [6]
    End point description
    IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality (e.g., feeling of fatigue "none of the time"). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life. Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. LOCF used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary efficacy end point was assessed only in subjects receiving double-blind treatment.
    End point values
    DB Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    16
    14
    Units: units on a scale
        arithmetic mean (standard deviation)
    27.8 ± 32.44
    1.8 ± 35.42
    No statistical analyses for this end point

    Secondary: Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

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    End point title
    Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment [7]
    End point description
    The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. LOCF used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary efficacy end point was assessed only in subjects receiving double-blind treatment.
    End point values
    DB Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    16
    14
    Units: units on a scale
        arithmetic mean (standard deviation)
    4.4 ± 9.09
    0.2 ± 6.31
    No statistical analyses for this end point

    Secondary: Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment

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    End point title
    Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment [8]
    End point description
    The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score). Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. LOCF used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary efficacy end point was assessed only in subjects receiving double-blind treatment.
    End point values
    DB Adalimumab 40 mg Eow DB Placebo Eow
    Number of subjects analysed
    16
    14
    Units: units on a scale
        arithmetic mean (standard deviation)
    9.6 ± 8.37
    0.3 ± 14.15
    No statistical analyses for this end point

    Other pre-specified: Number of Participants Who Had Clinical Remission at Week 148

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    End point title
    Number of Participants Who Had Clinical Remission at Week 148
    End point description
    Clinical remission=Crohn's Disease Activity Index (CDAI) < 150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    36
    Units: participants
        number (not applicable)
    21
    No statistical analyses for this end point

    Other pre-specified: Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points from Lead-in Study [NCT00445939] Baseline score) at Week 148

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    End point title
    Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points from Lead-in Study [NCT00445939] Baseline score) at Week 148
    End point description
    Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    36
    Units: participants
        number (not applicable)
    28
    No statistical analyses for this end point

    Other pre-specified: Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points from Lead-in Study [NCT00445939] Baseline Score) at Week 148

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    End point title
    Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points from Lead-in Study [NCT00445939] Baseline Score) at Week 148
    End point description
    Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    36
    Units: participants
        number (not applicable)
    26
    No statistical analyses for this end point

    Other pre-specified: Change in Crohn's Disease Activity Index from Baseline of Lead-in Study (NCT00445939) to Week 148

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    End point title
    Change in Crohn's Disease Activity Index from Baseline of Lead-in Study (NCT00445939) to Week 148
    End point description
    Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    36
    Units: units on a scale
        arithmetic mean (standard deviation)
    -143 ± 102.49
    No statistical analyses for this end point

    Other pre-specified: Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score from Baseline of Lead-in Study (NCT00445939) to Week 148

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    End point title
    Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score from Baseline of Lead-in Study (NCT00445939) to Week 148
    End point description
    The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    35
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1.7 ± 1.41
    No statistical analyses for this end point

    Other pre-specified: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) from Baseline of Lead-in Study (NCT00445939) to Week 148

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    End point title
    Change in Inflammatory Bowel Disease Questionnaire (IBDQ) from Baseline of Lead-in Study (NCT00445939) to Week 148
    End point description
    IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms & their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life [e.g., feeling of fatigue "all of the time"]; 7=good quality [e.g., feeling of fatigue "none of the time"]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    37
    Units: units on a scale
        arithmetic mean (standard deviation)
    27.2 ± 31.22
    No statistical analyses for this end point

    Other pre-specified: Change in Physical Component of the Short Form-36 Health Survey from Baseline of the Lead-in Study (NCT00445939) to Week 148

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    End point title
    Change in Physical Component of the Short Form-36 Health Survey from Baseline of the Lead-in Study (NCT00445939) to Week 148
    End point description
    The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health. Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    37
    Units: units on a scale
        arithmetic mean (standard deviation)
    5.44 ± 7.245
    No statistical analyses for this end point

    Other pre-specified: Change in Mental Component of the Short Form-36 Health Survey from Baseline of the Lead-in Study (NCT00445939) to Week 148

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    End point title
    Change in Mental Component of the Short Form-36 Health Survey from Baseline of the Lead-in Study (NCT00445939) to Week 148
    End point description
    The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score). Data is reported as observed cases. No imputation technique was used.
    End point type
    Other pre-specified
    End point timeframe
    Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)
    End point values
    Any Adalimumab
    Number of subjects analysed
    37
    Units: units on a scale
        arithmetic mean (standard deviation)
    6.44 ± 11.173
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks for the double-blind (DB) treatments (adalimumab and placebo) and for the open-label adalimumab treatment. Overall study (maximum adalimumab treatment of 184 weeks plus 70-day follow-up period) for the Any Adalimumab group.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    DB Adalimumab 40 mg Eow
    Reporting group description
    Double-blind adalimumab 40 mg every other week (eow)

    Reporting group title
    DB Placebo Eow
    Reporting group description
    Double-blind adalimumab placebo every other week (eow)

    Reporting group title
    OL Adalimumab 40 mg Eow
    Reporting group description
    Open-label adalimumab 40 mg every other week (eow)

    Reporting group title
    Any Adalimumab
    Reporting group description
    All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).

    Serious adverse events
    DB Adalimumab 40 mg Eow DB Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 25 (8.00%)
    7 / 25 (28.00%)
    20 / 32 (62.50%)
    49 / 79 (62.03%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Anaemia postoperative
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Investigations
    Blood phorphorus decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         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
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Dyspnoea exertional
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 32 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Headache
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Dizziness
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Hypoaesthesia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Pyrexia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 25 (4.00%)
    4 / 25 (16.00%)
    15 / 32 (46.88%)
    26 / 79 (32.91%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 18
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    2 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 32 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 32 (3.13%)
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         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
    Intestinal stenosis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    2 / 79 (2.53%)
         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
    Anal stenosis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Ileus
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    4 / 79 (5.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal stricture
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Nausea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Peritonitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal stenosis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    2 / 79 (2.53%)
         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
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Bile duct stone
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Cholelithiasis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    4 / 79 (5.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 32 (0.00%)
    0 / 79 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perianal abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         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
    Bacteraemia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         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
    Cellulitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Pneumonia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    1 / 79 (1.27%)
         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
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    DB Adalimumab 40 mg Eow DB Placebo Eow OL Adalimumab 40 mg Eow Any Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 25 (72.00%)
    16 / 25 (64.00%)
    30 / 32 (93.75%)
    76 / 79 (96.20%)
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    2 / 79 (2.53%)
         occurrences all number
    0
    1
    3
    3
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 25 (4.00%)
    10 / 32 (31.25%)
    22 / 79 (27.85%)
         occurrences all number
    6
    1
    17
    36
    Injection site reaction
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    6 / 79 (7.59%)
         occurrences all number
    2
    0
    2
    6
    Pain
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
    1 / 32 (3.13%)
    1 / 79 (1.27%)
         occurrences all number
    0
    2
    1
    1
    Pyrexia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
    5 / 32 (15.63%)
    17 / 79 (21.52%)
         occurrences all number
    2
    1
    7
    26
    Oedema peripheral
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    2
    3
    Chest pain
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    4 / 79 (5.06%)
         occurrences all number
    0
    1
    2
    5
    Malaise
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    4 / 79 (5.06%)
         occurrences all number
    0
    0
    1
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    10 / 79 (12.66%)
         occurrences all number
    0
    0
    4
    13
    Depression
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    2
    3
    Investigations
    Antinuclear antibody increased
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    7 / 79 (8.86%)
         occurrences all number
    2
    0
    2
    7
    Blood creatine phosphokinase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 25 (12.00%)
    3 / 32 (9.38%)
    6 / 79 (7.59%)
         occurrences all number
    1
    4
    3
    7
    C-reactive protein increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    4 / 79 (5.06%)
         occurrences all number
    0
    0
    1
    4
    DNA antibody positive
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    5 / 79 (6.33%)
         occurrences all number
    0
    1
    2
    5
    Gamma-glutamyltransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    6 / 79 (7.59%)
         occurrences all number
    1
    0
    1
    7
    Lymphocyte morphology abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    5 / 79 (6.33%)
         occurrences all number
    0
    0
    0
    9
    Weight decreased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    4 / 79 (5.06%)
         occurrences all number
    0
    0
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    4 / 25 (16.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    8 / 79 (10.13%)
         occurrences all number
    4
    0
    1
    9
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    5 / 32 (15.63%)
    11 / 79 (13.92%)
         occurrences all number
    0
    0
    6
    12
    Cough
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 32 (3.13%)
    6 / 79 (7.59%)
         occurrences all number
    0
    1
    1
    7
    Rhinitis allergic
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    4 / 79 (5.06%)
         occurrences all number
    1
    0
    2
    5
    Blood and lymphatic system disorders
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    6 / 32 (18.75%)
    12 / 79 (15.19%)
         occurrences all number
    1
    0
    8
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
    6 / 32 (18.75%)
    16 / 79 (20.25%)
         occurrences all number
    1
    2
    8
    33
    Dizziness
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    5 / 79 (6.33%)
         occurrences all number
    0
    1
    2
    5
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    4 / 79 (5.06%)
         occurrences all number
    0
    0
    4
    5
    Conjunctivitis
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    1
    1
    2
    3
    Eye discharge
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    2
    3
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 25 (12.00%)
    4 / 32 (12.50%)
    15 / 79 (18.99%)
         occurrences all number
    2
    3
    4
    18
    Dental caries
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 25 (4.00%)
    6 / 32 (18.75%)
    16 / 79 (20.25%)
         occurrences all number
    3
    1
    6
    19
    Dyspepsia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    2
    3
    Periproctitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    3
    3
    Abdominal pain
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    8 / 79 (10.13%)
         occurrences all number
    1
    1
    2
    8
    Abdominal pain upper
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    6 / 79 (7.59%)
         occurrences all number
    0
    0
    0
    6
    Diarrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    6 / 79 (7.59%)
         occurrences all number
    0
    0
    1
    6
    Nausea
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 32 (3.13%)
    9 / 79 (11.39%)
         occurrences all number
    0
    1
    1
    9
    Stomatitis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    4 / 79 (5.06%)
         occurrences all number
    1
    0
    1
    7
    Vomiting
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 32 (3.13%)
    5 / 79 (6.33%)
         occurrences all number
    0
    1
    1
    5
    Constipation
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    2
    2
    Toothache
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    2
    3
    Hepatobiliary disorders
    Hepatic function abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    4 / 79 (5.06%)
         occurrences all number
    0
    0
    1
    4
    Liver disorder
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    2
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    5 / 79 (6.33%)
         occurrences all number
    0
    0
    4
    7
    Rash
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    3 / 32 (9.38%)
    8 / 79 (10.13%)
         occurrences all number
    1
    1
    3
    8
    Eczema
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    4 / 32 (12.50%)
    6 / 79 (7.59%)
         occurrences all number
    1
    0
    4
    7
    Pruritus
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    3 / 32 (9.38%)
    8 / 79 (10.13%)
         occurrences all number
    1
    1
    6
    11
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    4 / 79 (5.06%)
         occurrences all number
    0
    0
    2
    6
    Urticaria
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    4 / 79 (5.06%)
         occurrences all number
    1
    0
    0
    4
    Dermatitis contact
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    4
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    6 / 79 (7.59%)
         occurrences all number
    1
    1
    2
    6
    Back pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    6 / 79 (7.59%)
         occurrences all number
    0
    0
    2
    8
    Myalgia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 32 (3.13%)
    5 / 79 (6.33%)
         occurrences all number
    0
    0
    1
    5
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    2
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 25 (56.00%)
    3 / 25 (12.00%)
    24 / 32 (75.00%)
    60 / 79 (75.95%)
         occurrences all number
    24
    4
    76
    213
    Tinea pedis
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
    0 / 32 (0.00%)
    3 / 79 (3.80%)
         occurrences all number
    2
    0
    0
    3
    Herpes simplex
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    7 / 79 (8.86%)
         occurrences all number
    1
    0
    8
    28
    Pharyngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    4 / 32 (12.50%)
    5 / 79 (6.33%)
         occurrences all number
    0
    0
    5
    6
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    6 / 79 (7.59%)
         occurrences all number
    0
    0
    4
    7
    Enteritis infectious
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    2 / 32 (6.25%)
    4 / 79 (5.06%)
         occurrences all number
    1
    1
    2
    4
    Gastroenteritis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 25 (0.00%)
    4 / 32 (12.50%)
    7 / 79 (8.86%)
         occurrences all number
    1
    0
    4
    7
    Cystitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 32 (6.25%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    2
    3
    Influenza
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    3 / 79 (3.80%)
         occurrences all number
    0
    0
    3
    3
    Sinusitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 32 (9.38%)
    2 / 79 (2.53%)
         occurrences all number
    0
    0
    3
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2007
    Allowed to taper and discontinue the concomitant medication, and dose escalation of the concomitant medication after the flare for the subjects with open-label adalimumab treatment after Week 12 of Study M06-837.
    09 Jun 2008
    Allowed to have self-injection after Week 52 of Study M06-837.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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