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    Clinical Trial Results:
    A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)

    Summary
    EudraCT number
    2015-000852-12
    Trial protocol
    BE   GB   NL   ES   FR  
    Global end of trial date
    14 Nov 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Vedolizumab-4003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02630966
    WHO universal trial number (UTN)
    U1111-1174-2252
    Sponsors
    Sponsor organisation name
    Takeda Takeda Development Centre Europe, Ltd.
    Sponsor organisation address
    61 Aldwych, WC2B 4AE, London, United Kingdom,
    Public contact
    Medical Director, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Scientific contact
    Medical Director, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Aug 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    34
    EEA total number of subjects
    28
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants took part in the study at 13 investigative sites in Canada, France, Italy, the Netherlands, Spain, the United Kingdom, and the United States from 10 August 2016 to 14 November 2018.

    Pre-assignment
    Screening details
    Participants with a diagnosis of moderately to severely active Crohn’s disease were randomized in a 1:1 ratio to receive vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14, 22 and a vedolizumab placebo-matching IV dose at Week 10 or vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14, and 22.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject, Carer, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group 1: Vedolizumab IV 300 mg + Placebo
    Arm description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab IV infusion
    Investigational medicinal product code
    Other name
    Entyvio MLN0002 Kynteles
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22.

    Investigational medicinal product name
    Vedolizumab placebo-matching IV infusion
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.

    Arm title
    Group 2: Vedolizumab 300 mg
    Arm description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab IV Infusion
    Investigational medicinal product code
    Other name
    Entyvio MLN0002 Kynteles
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.

    Number of subjects in period 1
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Started
    16
    18
    Completed
    14
    10
    Not completed
    2
    8
         Adverse event, non-fatal
    1
    3
         Voluntary Withdrawal
    -
    2
         Significant Protocol Deviation
    1
    1
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Vedolizumab IV 300 mg + Placebo
    Reporting group description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.

    Reporting group title
    Group 2: Vedolizumab 300 mg
    Reporting group description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.

    Reporting group values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg Total
    Number of subjects
    16 18 34
    Age categorical
    Units: Subjects
        From 18-64 years
    16 18 34
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    35.1 ± 10.35 35.1 ± 10.67 -
    Sex: Female, Male
    Units: Subjects
        Female
    6 7 13
        Male
    10 11 21
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 0 0
        Not Hispanic or Latino
    2 3 5
        Unknown or Not Reported
    14 15 29
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    1 0 1
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    1 0 1
        White
    12 15 27
        More than one race
    0 0 0
        Unknown or Not Reported
    2 3 5
    Smoking Classification
    Units: Subjects
        Never-smoker|
    7 8 15
        Current smoker|
    7 4 11
        Ex-smoker|
    2 6 8
    Region of Enrollment
    Units: Subjects
        Canada|
    1 0 1
        France|
    2 3 5
        Italy|
    5 6 11
        Netherlands|
    2 3 5
        Spain|
    3 2 5
        United Kingdom|
    1 1 2
        United States|
    2 3 5
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    170.1 ± 6.35 176.4 ± 10.38 -
    Weight
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    73.65 ± 15.986 68.36 ± 14.661 -
    Body Mass Index (BMI)
    Body Mass Index=weight/[height^2]
    Units: kg per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    25.40 ± 5.080 21.84 ± 3.580 -

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Vedolizumab IV 300 mg + Placebo
    Reporting group description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.

    Reporting group title
    Group 2: Vedolizumab 300 mg
    Reporting group description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.

    Primary: Percentage of Participants with at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline)

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    End point title
    Percentage of Participants with at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) [1]
    End point description
    Closed fistulae are no longer draining despite gentle finger compression. Modified Full Analysis Set (mFAS) included all participants in FAS who had at least one draining fistula at baseline (Day 1). FAS included all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing. Data is reported for participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Day 1, Week 30
    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: Statistical analysis was not available for this endpoint.
    End point values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Number of subjects analysed
    12
    8
    Units: percentage of participants
        number (confidence interval 95%)
    75.0 (50.5 to 99.5)
    75.0 (45.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with at Least 50% Reduction of from Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) at Both Weeks 22 and 30

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    End point title
    Percentage of Participants with at Least 50% Reduction of from Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) at Both Weeks 22 and 30
    End point description
    Closed fistulae are no longer draining despite gentle finger compression. The mFAS includes all participants in the FAS who had at least one draining fistula at baseline (Day 1). The FAS includes all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing.
    End point type
    Secondary
    End point timeframe
    Weeks 22 and 30
    End point values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Number of subjects analysed
    11
    8
    Units: percentage of participants
        number (confidence interval 95%)
    72.7 (46.4 to 99.0)
    62.5 (24.5 to 91.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline)

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    End point title
    Percentage of Participants with 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline)
    End point description
    Closed fistulae are no longer draining despite gentle finger compression. The mFAS included all participants in the FAS who had at least one draining fistula at baseline (Day 1). The FAS included all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing.
    End point type
    Secondary
    End point timeframe
    Week 30
    End point values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Number of subjects analysed
    12
    8
    Units: percentage of participants
        number (confidence interval 95%)
    58.3 (30.4 to 86.2)
    62.5 (24.5 to 91.5)
    No statistical analyses for this end point

    Secondary: Time to First Perianal Fistulae Closure

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    End point title
    Time to First Perianal Fistulae Closure
    End point description
    Closed fistulae are no longer draining despite gentle finger compression. The time to first fistula closure was analyzed descriptively using Kaplan-Meier product limit methods, with participants for which no fistula closure is reported being censored at the time of their last fistulae assessment or date of last record (Week 30 or early discontinuation). Estimated median time to fistula closure (and 95%CI) are reported.mFAS included participants in FAS with >=1 draining fistula at baseline (Day 1). FAS included all randomized participants who received >=1 dose of study drug, have a post-baseline assessment of fistula healing. 99999: Upper limit of 95% of confidence interval (CI) was not estimable due to low number of participant with events.
    End point type
    Secondary
    End point timeframe
    Up to Week 30
    End point values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Number of subjects analysed
    14
    14
    Units: days
        median (confidence interval 95%)
    30.5 (15.0 to 71.0)
    159.0 (16.0 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Last (100%) Perianal Fistulae Closure

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    End point title
    Time to Last (100%) Perianal Fistulae Closure
    End point description
    Closed fistulae are no longer draining despite gentle finger compression. The time to first fistula closure was analyzed descriptively using Kaplan-Meier product limit methods, with participants for which no fistula closure is reported being censored at the time of their last fistulae assessment or date of last record (Week 30 or early discontinuation). Estimated median time to fistula closure (and 95%CI) are reported. mFAS included participants in FAS with >=1 draining fistula at baseline (Day 1). FAS included all randomized participants who received >=1 dose of study drug, have a post-baseline assessment of fistula healing. 99999: Upper limit of 95% CI was not estimable due to low number of participant with events.
    End point type
    Secondary
    End point timeframe
    Up to Week 30
    End point values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Number of subjects analysed
    14
    14
    Units: days
        median (confidence interval 95%)
    45.0 (15.0 to 155.0)
    159.0 (16.0 to 99999)
    No statistical analyses for this end point

    Secondary: Duration of Perianal Fistulae Response

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    End point title
    Duration of Perianal Fistulae Response
    End point description
    Duration of fistula response was measured by number of days with/without drainage. Duration of perianal fistula response (days) was derived as the sum of days with perianal fistula response between Day 1 and the end of the study (Week 30 or early discontinuation). Perianal fistula response is defined as reduction in the number of draining perianal fistulae (of those draining at Baseline) draining of at least 50%. The mFAS included all participants in the FAS who had at least one draining fistula at baseline (Day 1). The FAS included all randomized participants who received at least 1 dose of study medication and have a post-baseline assessment of fistula healing.
    End point type
    Secondary
    End point timeframe
    Up to Week 30
    End point values
    Group 1: Vedolizumab IV 300 mg + Placebo Group 2: Vedolizumab 300 mg
    Number of subjects analysed
    14
    14
    Units: days
        median (full range (min-max))
    158.5 (0 to 202)
    33.5 (0 to 203)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 44 weeks
    Adverse event reporting additional description
    At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study medication.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Group 2: Vedolizumab 300 mg
    Reporting group description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.

    Reporting group title
    Group 1: Vedolizumab IV 300 mg + Placebo
    Reporting group description
    Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV infusion once, at Week 10 to maintain the blind.

    Serious adverse events
    Group 2: Vedolizumab 300 mg Group 1: Vedolizumab IV 300 mg + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 16 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Hyperpyrexia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 16 (18.75%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group 2: Vedolizumab 300 mg Group 1: Vedolizumab IV 300 mg + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 18 (94.44%)
    15 / 16 (93.75%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Catheter site bruise
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 16 (12.50%)
         occurrences all number
    4
    3
    Granuloma
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Catarrh
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Product issues
    Device expulsion
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Device loosening
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Wound dehiscence
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 16 (12.50%)
         occurrences all number
    5
    2
    Migraine
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Lymphadenitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Proctalgia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    Anorectal discomfort
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Rectal discharge
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Rectal stenosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Crohn's disease
         subjects affected / exposed
    5 / 18 (27.78%)
    1 / 16 (6.25%)
         occurrences all number
    5
    1
    Toothache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Abdominal tenderness
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 16 (25.00%)
         occurrences all number
    2
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dyschezia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Anal fistula
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    3
    4
    Subileus
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Oral pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Alopecia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Neutrophilic dermatosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Papule
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Neurodermatitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Erythema nodosum
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dermatitis psoriasiform
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Dermal cyst
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin mass
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Skin striae
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cutaneous vasculitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    5 / 18 (27.78%)
    1 / 16 (6.25%)
         occurrences all number
    7
    1
    Myalgia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Tendon pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Spondylitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    4
    Tooth infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Campylobacter infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Anal fistula infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Ear infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Fungal infection
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Perineal abscess
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    Rhinitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Feb 2016
    Amendment 1: •Requirements for perianal seton placement and seton removal were removed •Stratification factor was added for seton or no seton at randomization •Secondary endpoint to evaluate fistulas healed at both Week 22 and Week 30 was added •Modified inclusion criterion 6, 10, 11, exclusion criterion 6, 7, 17 and 19 per updated safety language and to remove the option of 5 half-lives as washout window, also some criterions were modified to allow additional types of antibiotics to reduce the incidence of abscess •Study sample size was reduced from 126 (63 per group) to 100 (50 per group) •Number of study sites were increased from 30 to 40 •Rationale for the proposed study was revised given that perianal seton replacement no longer required •Maximum dose of oral corticosteroids was changed from 30 to 20 mg/day.
    20 Apr 2017
    Amendment 5: •Requirement for perianal seton placement seton removal was removed, stratification factor was added for seton or no seton at randomization •Secondary endpoint to evaluate fistulas healed at both Week 22 and Week 30 was added •Modified inclusion criterion 6, 10, 11, exclusion criterion 6, 7, 17 and 19 per updated safety language and to remove the option of 5 half-lives as washout window, also some criterions were modified to allow additional types of antibiotic to reduce the incidence of abscess •Study sample size was reduced from 126 (63 per group) to 100 (50 per group) •Number of study sites were increased from 30 to 40. Rationale for the proposed study was revised given that perianal seton replacement no longer required •Schematic of Study Design was modified •Maximum dose of oral corticosteroids was changed from 30 to 20 mg/day.

    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.
    Takeda decided to close enrollment after randomizing 34 participants.Decision was taken due to challenges in recruitment and was not related to any safety concerns.Participants randomized before enrollment closure continued participation as planned.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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