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    Clinical Trial Results:
    A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE ®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    2006-000410-20
    Trial protocol
    DK   BE   IT   NL  
    Global end of trial date
    24 Jun 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jul 2016
    First version publication date
    15 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C0168T72
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00336492
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Centocor BV
    Sponsor organisation address
    Einsteinweg 101, 2333 , CB Leiden, Netherlands,
    Public contact
    Clinical Registry Group, Centocor BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Centocor BV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000240-PIP01-50
    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
    24 Jun 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy of a 3-dose induction regimen of infliximab in inducing clinical response, as measured by the Mayo score, in pediatric participants with moderately to severely active UC, and to evaluate the safety profile of infliximab during induction and maintenance treatment.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Known instances of nonconformance were documented and are not considered to have had an impact on the overall conclusions of this study. Safety was evaluated based on the variables like Adverse events, Clinical laboratory tests (hematology, serum chemistry), Vital sign measurements, Physical examinations, Tuberculosis testing, Antinuclear antibodies/anti-double-stranded DNA antibodies.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Aug 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    60
    EEA total number of subjects
    8
    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)
    15
    Adolescents (12-17 years)
    45
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 60 pediatric participants were enrolled at 23 investigational sites in North America and Europe.

    Pre-assignment
    Screening details
    A total of 60 participants were enrolled and included in the primary efficacy endpoint analysis and the safety analyses. At Week 8, 45 participants were randomized to 1 of 2 maintenance treatment regimens.

    Period 1
    Period 1 title
    Induction Regimen
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Open label

    Arms
    Arm title
    Infliximab 5 mg/kg
    Arm description
    All subjects treated at Week 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    infliximab 5 mg/kg administered at Weeks 0, 2, and 6

    Number of subjects in period 1
    Infliximab 5 mg/kg
    Started
    60
    Completed
    45
    Not completed
    15
         Other
    5
         Lack of efficacy
    6
         Adverse Event
    4
    Period 2
    Period 2 title
    Maintenance Treatment Regimen
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Infliximab 5 mg/kg q8 wks
    Arm description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 8 weeks (q8w) through Week 46.
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 8 weeks (q8w) through Week 46.

    Arm title
    Infliximab 5 mg/kg q12 wks
    Arm description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 12 weeks (q12w) through Week 42.
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 12 weeks (q12w) through Week 42.

    Arm title
    Not Randomized Group
    Arm description
    Participants who were not randomized at Week 8.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Infliximab 5 mg/kg q8 wks Infliximab 5 mg/kg q12 wks Not Randomized Group
    Started
    22
    23
    15
    Completed
    18
    12
    0
    Not completed
    4
    11
    15
         Other
    -
    1
    5
         Lack of efficacy
    1
    4
    6
         Adverse Event
    3
    6
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infliximab 5 mg/kg
    Reporting group description
    All subjects treated at Week 0.

    Reporting group values
    Infliximab 5 mg/kg Total
    Number of subjects
    60 60
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    15 15
        Adolescents (12-17 years)
    45 45
        Adults (18-64 years)
    0 0
        From 65 to 84 years
    0 0
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    13.4 ± 3.1 -
    Title for Gender
    Units: subjects
        Female
    32 32
        Male
    28 28

    End points

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    End points reporting groups
    Reporting group title
    Infliximab 5 mg/kg
    Reporting group description
    All subjects treated at Week 0.
    Reporting group title
    Infliximab 5 mg/kg q8 wks
    Reporting group description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 8 weeks (q8w) through Week 46.

    Reporting group title
    Infliximab 5 mg/kg q12 wks
    Reporting group description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 12 weeks (q12w) through Week 42.

    Reporting group title
    Not Randomized Group
    Reporting group description
    Participants who were not randomized at Week 8.

    Primary: The Number of Participants With Clinical Response at Week 8

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    End point title
    The Number of Participants With Clinical Response at Week 8 [1]
    End point description
    Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score (based on symptoms of ulcerative colitis) by greater than or equal to (>=) 30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.
    End point type
    Primary
    End point timeframe
    Week 8
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis has been planned for this endpoint.
    End point values
    Infliximab 5 mg/kg
    Number of subjects analysed
    60
    Units: Participants
    44
    No statistical analyses for this end point

    Secondary: The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54

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    End point title
    The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54
    End point description
    Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score less than (<) 10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    Infliximab 5 mg/kg q8 wks Infliximab 5 mg/kg q12 wks
    Number of subjects analysed
    21
    22
    Units: Participants
    8
    4
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis 1 for The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54.
    Comparison groups
    Infliximab 5 mg/kg q8 wks v Infliximab 5 mg/kg q12 wks
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.146
    Method
    Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 through Week 54
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    WHOART
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Subjects Not Randomized at Week 8
    Reporting group description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] at Weeks 0, 2,and 6.

    Reporting group title
    Infliximab 5 mg/kg q12 wks
    Reporting group description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 12 weeks (q12w) through Week 42.

    Reporting group title
    Infliximab 5 mg/kg q8 wks
    Reporting group description
    Infliximab was administered as 5 milligram per kilogram [mg/kg] in a maintenance treatment regimen every 8 weeks (q8w) through Week 46.

    Serious adverse events
    Subjects Not Randomized at Week 8 Infliximab 5 mg/kg q12 wks Infliximab 5 mg/kg q8 wks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    5 / 23 (21.74%)
    4 / 22 (18.18%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Lobar
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Cellulitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection Viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    4 / 15 (26.67%)
    3 / 23 (13.04%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary Tract Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    Subjects Not Randomized at Week 8 Infliximab 5 mg/kg q12 wks Infliximab 5 mg/kg q8 wks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    23 / 23 (100.00%)
    21 / 22 (95.45%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    2
    Hemorrhoids
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Cellulitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    ESR Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Fever
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 23 (4.35%)
    6 / 22 (27.27%)
         occurrences all number
    1
    1
    7
    Herpes Simplex
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Infection Bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Influenza
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 23 (8.70%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    1
    Inflammation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza-Like Symptoms
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 23 (8.70%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    Leukopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Moniliasis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Neutropenia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Chest Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    Chills
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Cyst (Type Unknown)
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Edema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Edema Peripheral
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    1 / 15 (6.67%)
    4 / 23 (17.39%)
    0 / 22 (0.00%)
         occurrences all number
    1
    4
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Thinking Abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Pallor
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Cyanosis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Palpitation
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Congenital Anomaly Nos
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Asthma
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Cold-Like Symptoms
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Coughing
         subjects affected / exposed
    1 / 15 (6.67%)
    3 / 23 (13.04%)
    2 / 22 (9.09%)
         occurrences all number
    1
    3
    3
    Dyspnea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    Pharyngitis
         subjects affected / exposed
    3 / 15 (20.00%)
    4 / 23 (17.39%)
    4 / 22 (18.18%)
         occurrences all number
    3
    5
    6
    Respiratory Tract Allergic Reaction
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    3
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    2
    Stridor
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Throat Tightness
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Upper Respiratory Tract Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    6 / 23 (26.09%)
    7 / 22 (31.82%)
         occurrences all number
    2
    9
    12
    Blood and lymphatic system disorders
    Anemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 23 (8.70%)
    4 / 22 (18.18%)
         occurrences all number
    0
    2
    4
    Antinuclear Factor Test Positive
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombocythemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 23 (8.70%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 15 (13.33%)
    3 / 23 (13.04%)
    3 / 22 (13.64%)
         occurrences all number
    2
    5
    6
    Muscle Contractions Involuntary
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperkinesia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    Glaucoma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Otitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis Media
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 15 (20.00%)
    2 / 23 (8.70%)
    3 / 22 (13.64%)
         occurrences all number
    3
    2
    3
    Blood in Stool
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Diarrhea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Colitis Ulcerative
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    15 / 23 (65.22%)
    7 / 22 (31.82%)
         occurrences all number
    1
    25
    8
    Diarrhea Bloody
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    3
    Stomatitis Ulcerative
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    3
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 23 (8.70%)
    1 / 22 (4.55%)
         occurrences all number
    1
    3
    2
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary Tract Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 23 (8.70%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    2
    Hepatobiliary disorders
    Hepatic Enzymes Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 23 (8.70%)
    0 / 22 (0.00%)
         occurrences all number
    0
    3
    0
    Hepatic Function Abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    SGOT Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    SGPT Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Alopecia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Onychocryptosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Onychomycosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    8
    Psoriasis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    Rash Pustular
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Skin Lesion
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Sweating Increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    4
    Verruca
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    2
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Bone Development Abnormal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Joint Stiffness
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Joint Swelling
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Osteopenia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Sprain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Malnutrition
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Serum Iron Decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    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
    01 Mar 2007
    The first amendment included clarifications about the conduct of the study and minor editorial changes. The major changes were as follows. Statements were added to describe postmarketing reports that link the occurrence of hepatosplenic T-cell lymphoma (HSTCL) with the concomitant use of immunomodulators in adolescent and young adult patients with Crohn’s disease. The required use of such immunomodulators concomitantly with infliximab during the study was removed. Planned enrollment was increased from 40 to 60 participants. Participants who had failed only treatment with 5-ASA compounds were allowed to enter the study. The definition of a positive study was modified and the primary analysis was revised. Intervals were changed between screening and the diagnosis of UC and between screening and the discontinuation or use of specific medications or therapies. The Pediatric Ulcerative Colitis Activity Index (PUCAI) was added as a measure of efficacy to be assessed at every visit at which a partial Mayo score was obtained and the major secondary endpoints were modified. The number of sigmoidoscopies required during the study was reduced. A DMC was added. Criteria for screening laboratory test results were revised
    04 Feb 2008
    The second amendment included modifications to concomitant medication and exclusion criteria, particularly with regard to corticosteroid use,a long with minor editorial changes.
    16 Oct 2008
    The third amendment updated the text about HSTCL to be consistent with both the informed consent form and the April 2008 risk update document.

    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.
    No notable study limitations were identified by the sponsor.
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