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    Summary
    EudraCT Number:2007-003239-21
    Sponsor's Protocol Code Number:C87091
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-01-15
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2007-003239-21
    A.3Full title of the trial
    A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home
    A.3.2Name or abbreviated title of the trial where available
    PERFECT
    A.4.1Sponsor's protocol code numberC87091
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 Powder for 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 (rINN)
    D.3.9.1CAS number 428863-50-7
    D.3.9.2Current sponsor codeCDP870
    D.3.9.3Other descriptive nameAnti TNF humanized antibody Fab fragment-PEG conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to +/- 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    To assess the clinical efficacy of certolizumab pegol 400mg in patients suffering from Crohn's disease administered subcutaneously at Weeks 0, 2 and 4 in two different settings (either at hospital or at-home) evaluated by clinical response at week 6
    E.2.2Secondary objectives of the trial
    To assess :
    • the clinical efficacy of certolizumab pegol in patients suffering from Crohn's disease administered in two different settings (either at hospital or at-home) evaluated by clinical response at week 14.
    • the impact of the self-administration in each setting (either at the hospital or at home) on the clinical efficacy in patients suffereing from Crohn's disease evaluated by the clinical response at Week 14
    • the clinical efficacy of certolizumab pegol in patients suffering from Crohn's disease administered in two different settings (either at hospital or at-home) evaluated by clinical remission at week 6 and 14.
    • the overall clinical safety and tolerability of certolizumab pegol in patients suffering from Crohn's disease administered in two different settings (either at hospital or at-home)
    • the impact of the self administration on the safety in patients suffering from Crohn's disease in each setting (either at the hospital or at home)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult men and women older than 18 years
    2. Diagnosis of Crohn’s disease confirmed
    3. Eligible to anti-TNF therapy
    4. HBI≥7
    5. Are able to understand the information provided to them and to give their written informed consent, which must be obtained prior to any study procedures
    6. Are registered to a health security system
    7. Female patient either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intra-uterine device; barrier and spermicide) abstinence is not an acceptable method).
    8. have screening laboratory results as follows :
    - ALT and AST levels not exceeding 2 times the upper limit of normal for the local lab
    - serum creatinine < or = to 1,7 mg/dl
    - platelets > or = to 100 000 cells/µL
    - neutrophils > or = to 1 500 cells/µL
    9. Have met all the concomitant medication criteria (5-ASA, antibiotics, corticosteroids, immunosuppressants)
    E.4Principal exclusion criteria
    Subjects with
    1. abscess or suspicion of abscess
    2. symptomatic known obstructive strictures or bowel perforation in last 6 months
    3. short bowel syndrome
    4. surgical bowel resection within the past 6 months or is planned resection at any time while enrolled in the study
    5. current diagnosis of ulcerative colitis or indeterminant colitis as determined by investigator or Sponsor
    6. ostomy or ileoanal pouch
    7. currently receiving total parenteral nutrition
    8. positive stool cultures for enteric pathogens during screening (e.g. C. difficile)
    9. Previous participation in a certolizumab pegol study
    10. treatment with any investigational agent within 5 half-lives prior to study drug administration
    11. treatment with infliximab within 8 weeks prior to the Baseline visit
    12. treatment with any other biologic product within 12 weeks prior to screening
    13. any prior exposure to natalizumab (Tysabri)
    14. history of drug or alcohol abuse
    15. Females who are pregnant or breast feeding
    16. Females of child bearing age not practicing effective birth control
    17. History of malignancy within last 5 years (except carcinoma –in situ of cervix or basal cell carcinoma that was successfully treated)
    18. History of lymphoproliferative disease
    19. History of human immunodeficiency disease (HIV), chronic or active hepatitis B or hepatitis C
    20. History of Congestive Heart Failure (CHF), including medically controlled asymptomatic CHF
    21. Has had a opportunistic infection within 6 months prior to screening
    22. Has had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 3 months prior to screening.
    23. Has a transplanted organ (except corneal transplant)
    24. Has had a chest x-ray within 8 weeks prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or active infection,
    25. History of a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
    26. any live virus or bacterial vaccination received within 3 months of first study drug administration, or planned during the trial or 3 months after last dose of study drug
    27. TB or positive PPD skin test or positive chest X-ray or patients in close contact with an individual with active TB
    28. History of known demyelinating disease
    29. Has signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or cerebral disease.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response rate at week 6 defined as HBI decrease from baseline ≥ 3 points.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    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 Information not present in EudraCT
    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 concerned42
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of the trial is defined as the Last Patient Last Visit date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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)
    For every patient enrolled in the study, after completion of the study or drop-out during the study, a safety follow-up visit will be scheduled 2 weeks after the last administration of the study drug.
    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 Decision2008-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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