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    Summary
    EudraCT Number:2006-003870-88
    Sponsor's Protocol Code Number:RPCE06G2013
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2006-003870-88
    A.3Full title of the trial
    A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I).
    A.3.2Name or abbreviated title of the trial where available
    COSPAR I
    A.4.1Sponsor's protocol code numberRPCE06G2013
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Pharma S.A.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecertolizumab pegol
    D.3.2Product code CDP870
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcertolizumab pegol
    D.3.9.2Current sponsor codeCDP870
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150+/- 15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePEGylated antibody Fab' fragment
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare certolizumab pegol and placebo treatments for the proportion of patients who have been successfully withdrawn from corticosteroids (prednisone or prednisolone) according to the tapering schedule of the protocol and have remained off corticosteroids and in disease remission as defined by a Crohn's Disease Activity Index (CDAI) of <=150 at Week 38 of treatment.
    E.2.2Secondary objectives of the trial
    ·Proportion of patients with remission (CDAI <=150) off steroids at each study visit·Proportion of patients with continuous remission (CDAI <=150) off steroids at each study visit · Cumulative proportion of patients with relapse/treatment failure at each study visit after Week 0, with relapse/treatment failure defined as a CDAI >150 and an increase in CDAI of >=70 points vs. Week 0 ·Time to relapse/treatment failure· Per-patient median weekly dose and cumulative dose of corticosteroids over the duration of the study, and change from baseline in the median weekly dose· CDAI scores at each study visit and changes from Week 0· Change from baseline in the health-related quality of life (HRQOL) as assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 38·Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient is able to understand the information provided to them and who have given written informed consent to the study. Patient is able to understand and complete self-administered questionnaires. Men and women, age 18 years or older
    A diagnosis of moderate to severe Crohn's disease (CDAI score of >= 220 - < =450) during the run-in period. The patient is a candidate for treatment with prednisone or prednisolone therapy, but is not on maintenance corticosteroid therapy
    If the patient is on an immunosuppressant (azathioprine, 6-mercaptopurine and methotrexate are allowed immunosuppressants), the dose has to have been stable for at least 8 weeks prior to screening and is expected to remain stable during the study. If the patient is on a 5-ASA analogue for Crohn’s disease, the dose has to have been stable for at least 4 weeks prior to screening and is expected to remain stable during the study. If female, the patient is either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptive; intrauterine device; barrier and spermicide—abstinence is not an acceptable method). Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab.
    E.4Principal exclusion criteria
    Patients who were primary non-responders to previous treatment with an anti-TNF drug are excluded. Patients with previous certolizumab pegol exposure are excluded.
    If a patient received ≤ 3 injections of anti-TNF therapy (other than certolizumab pegol) and responded to treatment, but discontinued that treatment for reasons other than loss of response or hypersensitivity reaction, the patient may be included in the study.
    Any patient receiving ≤ 3 injections of anti-TNF (other than certolizumab pegol) in the past 6 months must be reviewed by the UCB Study Physician prior to being included in the study.

    Active or draining fistula present at screening. On maintenance corticosteroid therapy. Symptomatic obstructive intestinal strictures. Functional colostomy or ileostomy (patients who have a temporary stoma in the past, which has been reversed, are eligible to enter the study). Bowel resection within 3 months of starting the study medication. Current total parenteral nutrition.Short bowel syndrome. Positive stool laboratory results for pathogens.Antibiotic treatment for Crohn’s Disease within 2 weeks prior to screening.

    Patients with a history of tuberculosis, or positive chest X-ray for tuberculosis, or positive PPD skin test result (defined as an induration of ≥5 mm) can not be enrolled in the study. Patients with a history of BCG vaccination having a positive PPD skin test, but no clinical or radiographic evidence of TB (confirmed by a radiologist) may be enrolled. Patient for which latent TB can not be ruled out are ONLY eligible for study entry if they are prophilactically treat with isoniazid initiated at least 1 month prior to re-screening and agree to maintain isoniazid therapy for six months.

    Patients with a previous history of blood dyscrasias are excluded from study participation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the proportion of patients who have been withdrawn from prednisone or prednisolone therapy according to the corticosteroid-tapering schedule and have remained off corticosteroids and in disease remission (CDAI <= 150) at Week 38.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For each subject, the study may last for up to 54 weeks [a run-in period of up to 6 weeks, treatment injections through Week 36, a final evaluation visit at Week 38, and telephone contact at Week 48 (or 12 weeks after treatment discontinuation).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-09-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 352
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Extension study ( C87065): An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-09
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