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    Clinical Trial Results:
    An Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents with Active Crohn's Disease Who Completed C87035 or Were Terminated from C87035 when the Study Was Stopped by UCB

    Summary
    EudraCT number
    2017-005025-20
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    27 Nov 2017

    Results information
    Results version number
    v2(current)
    This version publication date
    08 Oct 2020
    First version publication date
    10 Jun 2018
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Alignment with final posting on ClinicalTrials.gov after NIH review.

    Trial information

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    Trial identification
    Sponsor protocol code
    CR0012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES, INC.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, NC 27617
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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
    16 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the longterm safety and tolerability of certolizumab pegol (CZP) in children and adolescents with moderately to severely active Crohn's disease (CD) who completed or were terminated from C87035 (NCT00899678) when the study was stopped by UCB; and to assess the longterm efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment on this population.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    06 Aug 2010
    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
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    16
    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)
    4
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in August 2010 and concluded in November 2017.

    Pre-assignment
    Screening details
    The study included an Open Label treatment period, having 16 subjects enrolled in the Safety Set (SS) shown in the Participant Flow.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Certolizumab pegol: low-dose group (weight adjusted)
    Arm description
    200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 or 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg; 100 or 200 mg for subjects 20 to < 40 kg

    Arm title
    Certolizumab pegol: high-dose group (weight adjusted)
    Arm description
    400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 or 400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg; 100 or 200 mg for subjects 20 to < 40 kg

    Number of subjects in period 1
    Certolizumab pegol: low-dose group (weight adjusted) Certolizumab pegol: high-dose group (weight adjusted)
    Started
    4
    12
    Re-Induction
    0 [1]
    2 [2]
    Completed
    3
    3
    Not completed
    1
    9
         Lack of efficacy
    -
    2
         Administrative decision
    1
    -
         Adverse event, non-fatal
    -
    3
         Consent withdrawn by subject
    -
    2
         PI discretion
    -
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who had not been previously re-induced in C87035 and were eligible for 1 reinduction due to the loss of response in CR0012.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who had not been previously re-induced in C87035 and were eligible for 1 reinduction due to the loss of response in CR0012.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Certolizumab pegol: low-dose group (weight adjusted)
    Reporting group description
    200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Reporting group title
    Certolizumab pegol: high-dose group (weight adjusted)
    Reporting group description
    400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Reporting group values
    Certolizumab pegol: low-dose group (weight adjusted) Certolizumab pegol: high-dose group (weight adjusted) Total
    Number of subjects
    4 12 16
    Age categorical
    Units: Subjects
        <=18 years
    4 11 15
        Between 18 and 65 years
    0 1 1
        >=65 years
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    13.5 ± 2.4 13.9 ± 2.9 -
    Gender categorical
    Units: Subjects
        Female
    2 6 8
        Male
    2 6 8

    End points

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    End points reporting groups
    Reporting group title
    Certolizumab pegol: low-dose group (weight adjusted)
    Reporting group description
    200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Reporting group title
    Certolizumab pegol: high-dose group (weight adjusted)
    Reporting group description
    400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Subject analysis set title
    Certolizumab pegol: low-dose group (weight adjusted) – (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Subject analysis set title
    Certolizumab pegol: high-dose group (weight adjusted) – (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Subject analysis set title
    Certolizumab pegol: Re-Induction group – (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject’s weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject’s previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Subject analysis set title
    Certolizumab pegol: low-dose group (weight adjusted) – (ITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.

    Subject analysis set title
    Certolizumab pegol: high-dose group (weight adjusted) – (ITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Intention-to-Treat (ITT) Population included all subjects irrespective of any protocol deviations who received at least 1 injection of the study treatment and who had at least 1 efficacy measurement after the first injection of this study.

    Primary: Number of subjects reporting at least one Treatment-Emergent Adverse Event (TEAE) during study treatment (up to 303 weeks)

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    End point title
    Number of subjects reporting at least one Treatment-Emergent Adverse Event (TEAE) during study treatment (up to 303 weeks) [1]
    End point description
    Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
    End point type
    Primary
    End point timeframe
    During study treatment (up to 303 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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    Certolizumab pegol: low-dose group (weight adjusted) – (SS) Certolizumab pegol: high-dose group (weight adjusted) – (SS) Certolizumab pegol: Re-Induction group – (SS)
    Number of subjects analysed
    4
    10
    2
    Units: Participants
        Subjects
    2
    6
    2
    No statistical analyses for this end point

    Secondary: Number of subjects discontinuing treatment due to a Treatment-Emergent Adverse Event (TEAE)

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    End point title
    Number of subjects discontinuing treatment due to a Treatment-Emergent Adverse Event (TEAE)
    End point description
    Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
    End point type
    Secondary
    End point timeframe
    During study treatment (up to 303 weeks)
    End point values
    Certolizumab pegol: low-dose group (weight adjusted) – (SS) Certolizumab pegol: high-dose group (weight adjusted) – (SS) Certolizumab pegol: Re-Induction group – (SS)
    Number of subjects analysed
    4
    10
    2
    Units: Participants
        Subjects
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Number of subjects who develop anti-nuclear antibodies during the study

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    End point title
    Number of subjects who develop anti-nuclear antibodies during the study
    End point description
    Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
    End point type
    Secondary
    End point timeframe
    At the time of completion or termination visit (up to 298 weeks)
    End point values
    Certolizumab pegol: low-dose group (weight adjusted) – (ITT) Certolizumab pegol: high-dose group (weight adjusted) – (ITT)
    Number of subjects analysed
    3
    10
    Units: Participants
        Subjects
    0
    3
    No statistical analyses for this end point

    Secondary: Number of subjects who develop double-stranded deoxyribonucleic acid (dsDNA) antibodies during the study

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    End point title
    Number of subjects who develop double-stranded deoxyribonucleic acid (dsDNA) antibodies during the study
    End point description
    Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.
    End point type
    Secondary
    End point timeframe
    At the time of completion or termination visit (up to 298 weeks)
    End point values
    Certolizumab pegol: low-dose group (weight adjusted) – (ITT) Certolizumab pegol: high-dose group (weight adjusted) – (ITT)
    Number of subjects analysed
    3
    10
    Units: Participants
        Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects in clinical remission

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    End point title
    Percentage of subjects in clinical remission
    End point description
    Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)
    End point type
    Secondary
    End point timeframe
    At the time of completion or termination visit (up to 298 weeks)
    End point values
    Certolizumab pegol: low-dose group (weight adjusted) – (ITT) Certolizumab pegol: high-dose group (weight adjusted) – (ITT)
    Number of subjects analysed
    3
    9
    Units: Percentage of particpiants
    number (not applicable)
        percentage of subjects
    100
    44.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During study treatment (up to 303 weeks)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Certolizumab pegol: low-dose group (weight adjusted) – (SS)
    Reporting group description
    200 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 100 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Reporting group title
    Certolizumab pegol: Re-Induction group – (SS)
    Reporting group description
    If a subject had not been previously reinduced in C87035, the subject is eligible for 1 reinduction due to loss of response in CR0012. Reinduction Week 0 (first reinduction dose) is followed by Reinduction Week 2 (second dose, 2 weeks after first dose), and Reinduction Week 4 (third dose, 2 weeks after second dose). The reinduction dose was adjusted to the subject’s weight: 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg subcutaneously Q2W for a total of 3 doses. After reinduction was complete participants continued dosing with CZP administered subcutaneously Q4W as 400 mg for subjects ≥ 40 kg or 200mg for subjects 20 to < 40 kg, regardless of the subject’s previous randomized dose group). Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Reporting group title
    Certolizumab pegol: high-dose group (weight adjusted) – (SS)
    Reporting group description
    400 mg administered subcutaneously every 4 weeks for subjects >= 40 kg or 200 mg for subjects 20 to < 40 kg. Part of the Safety Set (SS) included all subjects enrolled, who received at least 1 injection of study treatment in this study.

    Serious adverse events
    Certolizumab pegol: low-dose group (weight adjusted) – (SS) Certolizumab pegol: Re-Induction group – (SS) Certolizumab pegol: high-dose group (weight adjusted) – (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    4 / 10 (40.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         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
    Crohn's disease
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (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
    Gastritis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Certolizumab pegol: low-dose group (weight adjusted) – (SS) Certolizumab pegol: Re-Induction group – (SS) Certolizumab pegol: high-dose group (weight adjusted) – (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    2 / 2 (100.00%)
    5 / 10 (50.00%)
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Ultrasound abdomen
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    6
    Asthma exercise induced
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    2
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    3
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Enuresis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    0
    0
    5
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    Stomatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    Abdominal tenderness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Crohn's disease
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Oesophagitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth impacted
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    5
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    Ear infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Furuncle
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Localised infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 10 (10.00%)
         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
    29 Jun 2010
    Amendment 1: - The telephone numbers for reporting serious adverse events (SAEs) during business hours or outside business hours have been indicated. - The inclusion and exclusion criteria were simplified to include subject who completed C87035. - Pregnancy due to oral contraceptive failure is not considered an SAE; the change was made to comply with Sponsor SAE reporting procedures. - An additional example of an important medical event relevant to subjects with Crohn’s disease (CD) (infections that require treatment with parental antibiotics) was provided. - An inconsistency in Visit 2 vital signs compared to Schedule of Study Assessments was corrected in Section 9.6.7.
    08 May 2012
    Amendment 2: - Following a meeting with the Food and Drug Administration (FDA) in Apr 2012, the decision was made to stop C87035 after determining it was inadequate to address the efficacy of certolizumab pegol (CZP) for labeling in pediatric subjects. - CR0012 was amended to allow subjects ongoing in C87035 to enter CR0012 without having completed C87035, and for treatment in CR0012 to be continued until a subject reached age of 18 years or CZP is approved for use in the US by pediatric subjects with Crohn’s disease (CD). - Additional updates were made to reflect the current UCB contacts, regulatory status of CZP, subject exposure, and to comply with the updated UCB definition of adverse events (AEs) of interest. - The format and style of the document was changed to comply with UCBs new document-authoring software; these changes are not specifically noted.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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