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    Summary
    EudraCT Number:2005-003977-25
    Sponsor's Protocol Code Number:C87043
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-003977-25
    A.3Full title of the trial
    A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease
    A.3.2Name or abbreviated title of the trial where available
    MUSIC
    A.4.1Sponsor's protocol code numberC87043
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 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
    D.3.9.1CAS number 428863-50-7
    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
    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 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
    To assess the efficacy of subcutaneous certolizumab pegol 400 mg in patients suffering from Crohn's disease at week 0, 2, 4 and 8. efficacy will be assessed using the CDEIS (Crohn's Disease Endoscopic Index of Severity) score at week 10 compared to baseline.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of subcutaneous certolizumab pegol 400 mg in patients suffering from Crohn's disease evaluated as the proportion of patients achieving mucosal healing (defined as complete absence of mucosal ulcerations) at week 10.

    To assess the clinical efficacy of subcutaneous certolizumab pegol 400 mg in patients suffering form Crohn's disease evaluated as improvement from the baseline in the mean histological Crohn's disease score (9) (combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes) at week 10.

    To assess the clinical efficacy of subcutaneous certolizumab pegol 400 mg in patients suffering from Crohn's disease evaluated as proportion of patients achieving clinical response (defined as a decrease of at least 100 points on CDAI score) at week 10.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients suffering from active Crohn's disease with CDAI NLT 220 and < 450 (scored over the 7 days prior to the first study treatment dose) and at least two segments with endoscopic ulcerative lesions with CDEIS NLT 8 at the baseline.
    - Adult men and women NLT 18 years of age.
    - Patients able to understand the information provided to them and give written informed consent.
    - Patients able to understand and complete self-administered questionnaires.
    - Female patients either postmenopausal for at one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier or spermicide). Abstinence is not an acceptable method. Patients must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol.
    - Patient having a social security system.
    - Concomitant medication; (6-ASA or antibiotics (stable for 4 weeks prior to screening), corticosteroids equivalent to or less than 30mg prednisolone per day (stable dose for 2 weeks), azathioprine and 6-mercaptopurine or methotrexate (stabel dose for 8 weeks) are allowed at baseline and during the study.
    E.4Principal exclusion criteria
    Crohn's disease related:
    - Symptomatic obstructive intestinal strictures.
    - Bowel resection within 4 weeks of starting the study medication.
    - Proctocolectomy or total colectomy.
    - Fistula present at screening.
    - Current total parental nutrition.
    - Short bowel syndrome.
    - Positive stool laboratory results for enteric pathogens.
    - Antibiotic treatment for non-Crohn's related infections within 3 weeks prior to screening.

    Medical History Exclusion:
    - Ulcerative colitis
    - lactating and/or pregnay female patients.
    - Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol afministration.
    - A history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough).
    - A history of tuberculosis or positive chest X-ray for tuberculosis or positive (defined as positive induration more than or equal to) PPD skin test. Patient with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB may be enrolled at the discretion of the Investigator. Consideration should be givn to the fact that a positive PPD skin test with prior vaccination does not include latent TB.
    - Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
    - Patients with known concurrent viral hepatitis or known positivity to HBe-Ag, HBV DNA, HBV DNA polymerase, HCV RNA, anti HCV antibodies.
    - Receipt of any vaccination (live or attenuated) within 8 weeks prior to Baseline (Influenza and Pneumococcal vaccines are allowed).
    - Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening.
    Current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastointestinal, endocrine, pulmonary, cardiac, neurological, or celebral disease.
    Known human immunodeficiency virus (HIV) infection.
    - New York Heart Association (NYHA) class III-IV congestive heart failure requiring medical treatment.
    - A histiry of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product.
    - Any other condition, which in the Investigator's judgement would make the patient unsuitable for inclusion in the study.
    - History of drug or alcohol abuse in the prior year.
    - Any modifications in the concomittant treatments (dose and/or frequency), other that those described above will be considered as non authorized concomittant medication.

    Previous clinical trials and previous biological therapy exclusion:
    - Previous treatment with a biological therapy for CD that resulted in a severe hypersensivity reaction, an anaphylactic reaction or lack or response.
    - Treatment with infliximab / adalimumab within 12 weeks prior to Visit 2
    - Previous treatment with natalizumab
    - Previous treatment with certolizumab pegol
    - Other biological therapy throughout the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the mean change from the baseline of CDEIS score at week 10. [The mean of primary efficacy endpoint, the change at week 10 from baseline in the CDEIS score, will be presented witha 95% confidence interval. It will be assumed that the endpoint is normally distributed for the purposes of the confidence interval calculation. The distribution of the endpoint will be plotted as a histogram and if it is found that the data do not appear to be normal then alternate methods will be used. These could include transforming the original data or a non-parametric 95% confidence interval around the median. Further some prognostic factors will also be investigated].
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 study is when marketing authorisation application for Certolizumab pegol for Crohn's disease indication is approved in the respective countries.
    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 months18
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 85
    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)
    An open label protocol extension until the drug is commercialized is currently being planned and will be submitted for approval.
    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 Decision2006-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
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