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    Clinical Trial Results:
    A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2007-002716-26
    Trial protocol
    BE   FI   HU   LV   EE   IT   CZ   AT  
    Global end of trial date
    22 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jan 2016
    First version publication date
    29 Jan 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C87088
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00552344
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES GmbH
    Sponsor organisation address
    Alfred-Nobel-Str. 10, Monheim, Germany, 40789
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 4815 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this clinical study was to assess the safety of long-term therapy with Certolizumab Pegol (CZP) in those subjects who participated in C87085.
    Protection of trial subjects
    No specific additional measurements to minimise pain and distress were required, the safety of the subjects was closely followed as usual.
    Background therapy
    Background therapy was not required, but it was allowed if subjects entered the study on stable dose of e.g. immunosuppressants, corticosteroids, 5-ASA analogues (see inclusion criteria of feeder study C87085) and kept this throughout the study.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    19 May 2008
    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
    Canada: 60
    Country: Number of subjects enrolled
    United States: 77
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Hungary: 47
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Latvia: 7
    Country: Number of subjects enrolled
    Poland: 28
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Ukraine: 19
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Brazil: 25
    Country: Number of subjects enrolled
    Israel: 19
    Country: Number of subjects enrolled
    New Zealand: 19
    Worldwide total number of subjects
    402
    EEA total number of subjects
    153
    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)
    393
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in May 2008 and concluded in Dec 2014. Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.

    Pre-assignment
    Screening details
    406 subjects were screened: 3 subjects were considered as screen failures and were not enrolled. 403 subjects entered the study from C87085. 1 subject was enrolled in this study, but did not receive any open-label study medication and was withdrawn from the study; this subject was, therefore, not included in any of the analyses.

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

    Arms
    Arm title
    Certolizumab Pegol
    Arm description
    Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Cimzia
    Investigational medicinal product code
    CDP870
    Other name
    CZP
    Pharmaceutical forms
    Solution for injection in pre-filled syringe, Powder for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    • Active substance: Certolizumab Pegol • Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe • Concentration: 200 mg/ml • Route of Administration: Subcutaneous use

    Number of subjects in period 1
    Certolizumab Pegol
    Started
    402
    Completed
    87
    Not completed
    315
         SAE, non-fatal + AE, non-serious non-fatal
             62
         Other Reason
             22
         SAE, fatal + AE, non-serious non-fatal
             1
         Loss of efficacy
             75
         Lack of efficacy
             55
         SAE, non-fatal
             6
         AE, non-serious non-fatal
             38
         Consent withdrawn by subject
             48
         Lost to follow-up
             8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Certolizumab Pegol
    Reporting group description
    Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

    Reporting group values
    Certolizumab Pegol Total
    Number of subjects
    402 402
    Age Categorical
    Units: Subjects
        18 - < 65 years
    393 393
        65 - < 85 years
    9 9
        >= 85 years
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    37.3 ± 12.68 -
    Gender Categorical
    Units: Subjects
        Male
    181 181
        Female
    221 221

    End points

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    End points reporting groups
    Reporting group title
    Certolizumab Pegol
    Reporting group description
    Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

    Subject analysis set title
    Certolizumab Pegol (Intention-to-Treat)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks. The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.

    Primary: Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 weeks)

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    End point title
    Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 weeks) [1]
    End point description
    An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    From study start to the end of the Safety Follow-up Period (up to 272 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 end point. Results were summarized in tables as descriptive statistics only.
    End point values
    Certolizumab Pegol
    Number of subjects analysed
    402
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    89.6
    No statistical analyses for this end point

    Primary: Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 weeks)

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    End point title
    Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 weeks) [2]
    End point description
    An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
    End point type
    Primary
    End point timeframe
    From study start to the end of the Safety Follow-up Period (up to 272 weeks)
    Notes
    [2] - 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 end point. Results were summarized in tables as descriptive statistics only.
    End point values
    Certolizumab Pegol
    Number of subjects analysed
    402
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    37.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)

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    End point title
    Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
    End point description
    HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
    End point type
    Secondary
    End point timeframe
    Week 262
    End point values
    Certolizumab Pegol (Intention-to-Treat)
    Number of subjects analysed
    397
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects (95 % CI)
    11.6 (8.4 to 14.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)

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    End point title
    Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
    End point description
    IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
    End point type
    Secondary
    End point timeframe
    Week 262
    End point values
    Certolizumab Pegol (Intention-to-Treat)
    Number of subjects analysed
    397
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects (95 % CI)
    7.8 (5.2 to 10.4)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Certolizumab Pegol after 1 year (Week 52)

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    End point title
    Plasma Concentration of Certolizumab Pegol after 1 year (Week 52)
    End point description
    Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab Pegol
    Number of subjects analysed
    402
    Units: μg/mL
    geometric mean (confidence interval 95%)
        geometric mean (95 % CI)
    6.317 (5.407 to 7.381)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088

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    End point title
    Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088
    End point description
    Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.
    End point type
    Secondary
    End point timeframe
    From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)
    End point values
    Certolizumab Pegol
    Number of subjects analysed
    402
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    10.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
    Adverse event reporting additional description
    Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Certolizumab Pegol
    Reporting group description
    Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

    Serious adverse events
    Certolizumab Pegol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    149 / 402 (37.06%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Arteritis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypotension
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Varicose vein
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    4 / 402 (1.00%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Victim of abuse
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Physical assault
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy on contraceptive
         subjects affected / exposed
    5 / 402 (1.24%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Pregnancy
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Mass
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Unevaluable event
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    3 / 402 (0.75%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Pelvic prolapse
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Menstrual disorder
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vaginal inflammation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anastomotic haemorrhage
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal anastomosis complication
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural inflammation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Transfusion-related acute lung injury
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Investigation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colonoscopy
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary mass
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary vasculitis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 402 (0.75%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Migraine
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Demyelination
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 402 (1.49%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Anal fistula
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    51 / 402 (12.69%)
         occurrences causally related to treatment / all
    8 / 59
         deaths causally related to treatment / all
    0 / 0
    Anorectal disorder
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolonic fistula
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal mucosal disorder
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileal fistula
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    11 / 402 (2.74%)
         occurrences causally related to treatment / all
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Intestinal stenosis
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    6 / 402 (1.49%)
         occurrences causally related to treatment / all
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal colic
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    5 / 402 (1.24%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic necrosis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    4 / 402 (1.00%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal abscess
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psoas abscess
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 402 (0.50%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 402 (1.24%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vulval abscess
         subjects affected / exposed
    1 / 402 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Certolizumab Pegol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    351 / 402 (87.31%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    28 / 402 (6.97%)
         occurrences all number
    30
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    39 / 402 (9.70%)
         occurrences all number
    49
    Oropharyngeal pain
         subjects affected / exposed
    23 / 402 (5.72%)
         occurrences all number
    27
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    34 / 402 (8.46%)
         occurrences all number
    45
    Nervous system disorders
    Headache
         subjects affected / exposed
    45 / 402 (11.19%)
         occurrences all number
    58
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    54 / 402 (13.43%)
         occurrences all number
    106
    Influenza like illness
         subjects affected / exposed
    23 / 402 (5.72%)
         occurrences all number
    40
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    127 / 402 (31.59%)
         occurrences all number
    191
    Abdominal pain
         subjects affected / exposed
    75 / 402 (18.66%)
         occurrences all number
    122
    Diarrhoea
         subjects affected / exposed
    61 / 402 (15.17%)
         occurrences all number
    93
    Nausea
         subjects affected / exposed
    46 / 402 (11.44%)
         occurrences all number
    63
    Vomiting
         subjects affected / exposed
    43 / 402 (10.70%)
         occurrences all number
    60
    Dyspepsia
         subjects affected / exposed
    32 / 402 (7.96%)
         occurrences all number
    37
    Abdominal pain upper
         subjects affected / exposed
    24 / 402 (5.97%)
         occurrences all number
    28
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    27 / 402 (6.72%)
         occurrences all number
    39
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    57 / 402 (14.18%)
         occurrences all number
    79
    Back pain
         subjects affected / exposed
    36 / 402 (8.96%)
         occurrences all number
    40
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    63 / 402 (15.67%)
         occurrences all number
    99
    Nasopharyngitis
         subjects affected / exposed
    46 / 402 (11.44%)
         occurrences all number
    88
    Influenza
         subjects affected / exposed
    30 / 402 (7.46%)
         occurrences all number
    35
    Urinary tract infection
         subjects affected / exposed
    25 / 402 (6.22%)
         occurrences all number
    31
    Bronchitis
         subjects affected / exposed
    21 / 402 (5.22%)
         occurrences all number
    32
    Sinusitis
         subjects affected / exposed
    29 / 402 (7.21%)
         occurrences all number
    48

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2008
    Protocol Amendment 1, dated 31 Jul 2008, was implemented after 37 subjects were enrolled in the study. The protocol was amended: - To change the planned study period from a Treatment Period of 50 weeks (plus Safety Follow-up (SFU)) to 262 weeks (plus SFU) to allow for up to 5 years of treatment with Certolizumab Pegol (CZP). - To amend the inclusion criteria to allow enrollment of subjects only if they had completed the Treatment Period of C87085 prior to enrolling into C87088. - To correct typographical errors and to clarify further inconsistencies.
    28 May 2010
    Protocol Amendment 2, dated 28 May 2010, was implemented after 401 subjects were enrolled in the study. The protocol was amended: - To initiate implementation of the switch from administration of the reconstituted, lyophilized powder formulation of CZP to the bioequivalent, liquid formulation supplied in the prefilled syringe (PFS).To change the name and contact information for the Study Physician and Clinical Project Manager to reflect recent personnel changes at UCB. - To update the phone numbers for serious adverse event (SAE) reporting. - To update the List of Abbreviations to reflect the changes to the protocol. - To adapt recruitment numbers to reflect the actual recruitment status at the time of the amendment. - To correct information on autoantibody samples that were previously mistakenly labeled in the protocol as plasma samples but were actually serum samples. As per the laboratory manual used for this study, these samples were drawn and processed as serum samples since the beginning of the study. Due to an oversight, this information was not changed from “plasma” to “serum” samples in Protocol Amendment 1. - To revise the schedule of assessments to include instructions for switching subjects from CZP lyophilized powder to PFS, and to change “plasma”-autoantibodies to “serum”-autoantibodies. - To update the protocol with information on the clinical supply of CZP PFS (description, packaging, and labeling) to be used in the switch from the lyophilized formulation to PFS. - To update the protocol with details of the switch from the lyophilized powder formulation of CZP to the PFS. - To add updates and clarifications to the definitions, reporting procedures, and follow up for adverse events (AEs), pregnancies, and SAEs, and to add a subsection to the protocol on AEs of special interest. - To correct Financial Disclosure responsibilities to comply with UCB's current Standard Operating Procedures (SOPs). - To make administrative changes.

    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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