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

    Summary
    EudraCT number
    2014-004560-38
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    25 Dec 2007

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    07 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M04-729
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00445939
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Morio Ozawa, AbbVie, morio.ozawa@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Dec 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Feb 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: 90
    Worldwide total number of subjects
    90
    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)
    3
    Adults (18-64 years)
    87
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects with moderate to severe Crohn's Disease (Crohn's Disease Activity Index [CDAI] >= 220 and <= 450) were enrolled into study. The period from the first dose of study drug to the evaluation at Week 4 is Period A. The period from the study drug injection at Week 4 to the evaluation at Week 8 is Period B.

    Pre-assignment
    Screening details
    All subjects were evaluated at Week 4. If responders (CDAI decrease >= 70 points compared to Baseline), rolled over to a maintenance study. If non-responders (CDAI decrease of < 70 points compared to Baseline), continued in study and received: adalimumab 160/80 mg + 40/40 mg, or adalimumab 80/40 mg + 40/40 mg or placebo + adalimumab 160/80 mg.

    Period 1
    Period 1 title
    Period A - Week 0 - Week 4
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Period A - Adalimumab 160 mg/80 mg
    Arm description
    Adalimumab 160 mg at Week 0, 80 mg at Week 2
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    160 mg at Week 0, 80 mg at Week 2

    Arm title
    Period A - Adalimumab 80 mg/40 mg
    Arm description
    Adalimumab 80 mg at Week 0, 40 mg at Week 2
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    80 mg at Week 0, 40 mg at Week 2

    Arm title
    Period A - Placebo
    Arm description
    Placebo at Week 0, placebo at Week 2
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo at Week 0 and Week 2

    Number of subjects in period 1
    Period A - Adalimumab 160 mg/80 mg Period A - Adalimumab 80 mg/40 mg Period A - Placebo
    Started
    33
    34
    23
    Completed
    32
    32
    23
    Not completed
    1
    2
    0
         Adverse event
             1
             2
             -
    Period 2
    Period 2 title
    Period B - Week 4 - Week 8
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Period B - Adalimumab 160 mg/80 mg
    Arm description
    Non-responders continued after 4 weeks, placebo at Week 0 and Week 2 (Period A), adalimumab 160 mg at Week 4, 80 mg at Week 6 (Period B)
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    160 mg at Week 4, 80 mg at Week 6

    Arm title
    Period B - Adalimumab 40 mg /40 mg
    Arm description
    Non-responders continued after 4 weeks, adalimumab 160 at Week 0, 80 mg at Week 2 or adalimumab 80 mg at Week 0, 40 mg at Week 2 (Period A), 40 mg at Week 4, 40 mg at Week 6 (Period B)
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    ABT-D2E7, Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg at Week 4, 40 mg at Week 6

    Number of subjects in period 2 [1]
    Period B - Adalimumab 160 mg/80 mg Period B - Adalimumab 40 mg /40 mg
    Started
    16
    21
    Completed
    14
    20
    Not completed
    2
    1
         Adverse event
             2
             1
    Notes
    [1] - 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: All subjects were evaluated at Week 4; responders were rolled over into a maintenance study (Adalimumab 160 mg/80 mg, n=23; Adalimumab 80 mg/40 mg, n=20; and Placebo, n=7). Non-responders continued after 4 weeks; previous 16 placebo subjects allocated to 160/80 mg group in Period 2; previous 160/80 (n=9) and 80/40 mg (n=12) subjects allocated to the 40/40 group in Period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period A - Adalimumab 160 mg/80 mg
    Reporting group description
    Adalimumab 160 mg at Week 0, 80 mg at Week 2

    Reporting group title
    Period A - Adalimumab 80 mg/40 mg
    Reporting group description
    Adalimumab 80 mg at Week 0, 40 mg at Week 2

    Reporting group title
    Period A - Placebo
    Reporting group description
    Placebo at Week 0, placebo at Week 2

    Reporting group values
    Period A - Adalimumab 160 mg/80 mg Period A - Adalimumab 80 mg/40 mg Period A - Placebo Total
    Number of subjects
    33 34 23 90
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32 ± 9.6 30.6 ± 9.26 30.4 ± 6.93 -
    Gender categorical
    Gender, Male/Female who received first dose of study drug
    Units: Subjects
        Female
    13 18 7 38
        Male
    20 16 16 52

    End points

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    End points reporting groups
    Reporting group title
    Period A - Adalimumab 160 mg/80 mg
    Reporting group description
    Adalimumab 160 mg at Week 0, 80 mg at Week 2

    Reporting group title
    Period A - Adalimumab 80 mg/40 mg
    Reporting group description
    Adalimumab 80 mg at Week 0, 40 mg at Week 2

    Reporting group title
    Period A - Placebo
    Reporting group description
    Placebo at Week 0, placebo at Week 2
    Reporting group title
    Period B - Adalimumab 160 mg/80 mg
    Reporting group description
    Non-responders continued after 4 weeks, placebo at Week 0 and Week 2 (Period A), adalimumab 160 mg at Week 4, 80 mg at Week 6 (Period B)

    Reporting group title
    Period B - Adalimumab 40 mg /40 mg
    Reporting group description
    Non-responders continued after 4 weeks, adalimumab 160 at Week 0, 80 mg at Week 2 or adalimumab 80 mg at Week 0, 40 mg at Week 2 (Period A), 40 mg at Week 4, 40 mg at Week 6 (Period B)

    Subject analysis set title
    Adaliumab 160 mg/80 mg + 40/40 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6

    Subject analysis set title
    Adalimumab 80 mg/40 mg + 40/40 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6

    Subject analysis set title
    Placebo + Adalimumab 160/80 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Placebo at Week 0, placebo at Week 2, adalimumab 160 mg at Week 4, and adalimumab 80 mg at Week 6

    Primary: Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4

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    End point title
    Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 [1]
    End point description
    CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4. The primary analysis will be performed on the full analysis set (FAS: randomized subjects who received at least one dose of study drug) using the non-responder imputation (NRI) for missing remission observations.
    End point type
    Primary
    End point timeframe
    4 weeks
    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 were summarized for this end point per protocol.
    End point values
    Period A - Adalimumab 160 mg/80 mg Period A - Adalimumab 80 mg/40 mg Period A - Placebo
    Number of subjects analysed
    33
    34
    23
    Units: participants
    11
    6
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Remission (CDAI < 150) at Week 2

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    End point title
    Number of Subjects With Clinical Remission (CDAI < 150) at Week 2
    End point description
    Number of subjects in each treatment group in clinical remission (CDAI < 150) in the FAS using NRI at Week 2. CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Period A - Adalimumab 160 mg/80 mg Period A - Adalimumab 80 mg/40 mg Period A - Placebo
    Number of subjects analysed
    33
    34
    23
    Units: Participants
    6
    5
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Response (CR-70 and CR-100) in Period A

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    End point title
    Number of Subjects With Clinical Response (CR-70 and CR-100) in Period A
    End point description
    The number of subjects in each treatment group with a CR-70 (CDAI decrease of >=70 compared to Baseline) and CR-100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4. CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Subjects in the FAS are included in the analysis.
    End point type
    Secondary
    End point timeframe
    Week 2 and Week 4
    End point values
    Period A - Adalimumab 160 mg/80 mg Period A - Adalimumab 80 mg/40 mg Period A - Placebo
    Number of subjects analysed
    33
    34
    23
    Units: Participants
        CR-70 at Week 2
    15
    17
    4
        CR-70 at Week 4
    23
    20
    7
        CR-100 at Week 2
    10
    11
    2
        CR-100 at Week 4
    15
    17
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Response (CR-70 and CR-100) in Period B

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    End point title
    Number of Subjects With Clinical Response (CR-70 and CR-100) in Period B
    End point description
    The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and CR-100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8. CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Full analysis set - subjects rated as non-responders (did not attain CDAI reduction >= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8, descriptive statistics were performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg.
    End point type
    Secondary
    End point timeframe
    Week 6 and Week 8
    End point values
    Adaliumab 160 mg/80 mg + 40/40 mg Adalimumab 80 mg/40 mg + 40/40 mg Placebo + Adalimumab 160/80 mg
    Number of subjects analysed
    9
    12
    16
    Units: Participants
        CR-70 at Week 6
    1
    4
    9
        CR-70 at Week 8
    3
    5
    12
        CR-100 at Week 6
    0
    1
    3
        CR-100 at Week 8
    0
    2
    7
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Remission (CDAI <150) at Week 6 and Week 8

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    End point title
    Number of Subjects With Clinical Remission (CDAI <150) at Week 6 and Week 8
    End point description
    The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with NRI at Week 6 and Week 8. CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Subjects who were rated as non-responders (CDAI reduction < 70) in the evaluation of clinical remission (CDAI < 150) at Week 4. For Week 6 and Week 8, descriptive statistics were performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg.
    End point type
    Secondary
    End point timeframe
    Week 6 and Week 8
    End point values
    Adaliumab 160 mg/80 mg + 40/40 mg Adalimumab 80 mg/40 mg + 40/40 mg Placebo + Adalimumab 160/80 mg
    Number of subjects analysed
    33
    34
    23
    Units: Participants
        Clinical Remission at Week 6
    0
    1
    2
        Clinical Remission at Week 8
    0
    1
    2
    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 were collected from time of study drug administration to 70 days after last dose of study drug.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Adalimumab 160 mg/80 mg
    Reporting group description
    Adalimumab 160 mg at Week 0, 80 mg at Week 2

    Reporting group title
    Adalimumab 80 mg/40 mg
    Reporting group description
    Adalimumab 80 mg at Week 0, 40 mg at Week 2

    Reporting group title
    Placebo
    Reporting group description
    Placebo at Week 0, placebo at Week 2

    Reporting group title
    Adalimumab 160 mg/80 mg + 40/40 mg
    Reporting group description
    Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6

    Reporting group title
    Adalimumab 80/40 mg + 40/40 mg
    Reporting group description
    Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6

    Reporting group title
    Placebo + Adalimumab 160/80 mg
    Reporting group description
    Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6

    Serious adverse events
    Adalimumab 160 mg/80 mg Adalimumab 80 mg/40 mg Placebo Adalimumab 160 mg/80 mg + 40/40 mg Adalimumab 80/40 mg + 40/40 mg Placebo + Adalimumab 160/80 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 34 (8.82%)
    2 / 23 (8.70%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    C-reactive protein increased (at investigator's discretion)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    2 / 23 (8.70%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adalimumab 160 mg/80 mg Adalimumab 80 mg/40 mg Placebo Adalimumab 160 mg/80 mg + 40/40 mg Adalimumab 80/40 mg + 40/40 mg Placebo + Adalimumab 160/80 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 33 (39.39%)
    15 / 34 (44.12%)
    8 / 23 (34.78%)
    5 / 9 (55.56%)
    9 / 12 (75.00%)
    8 / 16 (50.00%)
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    1 / 23 (4.35%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    0
    Application site swelling
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Injection site erythema
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 34 (5.88%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 34 (8.82%)
    2 / 23 (8.70%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    1
    3
    2
    0
    1
    0
    Instillation site pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 34 (8.82%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 34 (5.88%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Investigations
    Antinuclear antibody increased (at investigator's discretion)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Blood albumin decreased (at investigator's discretion)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Blood creatine phosphokinase increased (at investigator's discretion)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Blood glucose increased (at investigator's discretion)
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 34 (8.82%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 33 (9.09%)
    0 / 34 (0.00%)
    1 / 23 (4.35%)
    0 / 9 (0.00%)
    2 / 12 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    3
    0
    1
    0
    2
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 23 (4.35%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Constipation
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    1 / 23 (4.35%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 23 (4.35%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Intestinal obstruction
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    3 / 23 (13.04%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    1 / 23 (4.35%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Hepatobiliary disorders
    Hepatic function abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 34 (5.88%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    1 / 23 (4.35%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Glucose tolerance impaired (at investigator's discretion)
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Hypoglycaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 23 (0.00%)
    1 / 9 (11.11%)
    1 / 12 (8.33%)
    3 / 16 (18.75%)
         occurrences all number
    0
    1
    0
    1
    1
    3
    Tonsillitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 34 (2.94%)
    1 / 23 (4.35%)
    1 / 9 (11.11%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    1
    1
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 23 (0.00%)
    0 / 9 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    1

    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
    To add the severity of Crohn's disease history in original case report form.

    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.
    Small population, therefore no statistical tests were performed.
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