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    Summary
    EudraCT Number:2007-001913-41
    Sponsor's Protocol Code Number:C87085
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-001913-41
    A.3Full title of the trial
    A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease.
    A.4.1Sponsor's protocol code numberC87085
    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 Celltech
    B.1.3.4CountryUnited Kingdom
    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 to +/- 15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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
    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 efficacy of certolizumab pegol versus placebo for induction of clinical remission in subjects with moderately to severely active Crohn’s disease.
    E.2.2Secondary objectives of the trial
    To assess the effect of certolizumab pegol on induction of clinical response
    To assess the impact of certolizumab pegol on the IBDQ
    To assess the safety of certolizumab pegol therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Crohn’s disease confirmed (at least 3 months prior to screening visit) by either radiological or endoscopic evidence.
    2. Visualization of the GI tract by endoscopic or histological examination within the past 12 months.
    3. Moderately to severely active Crohn’s disease (CDAI ≥ 220 ≤ 450) scored over the 7 days prior to the Baseline visit
    4. No previous treatment with an anti-TNF agent
    5. Male or female aged 18-75 years old
    6. Are considered eligible according to the TB screening criteria.
    7. Have screening laboratory results as follows:
    Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels not exceeding 2 times the upper limit of normal for the central laboratory conducting the test.
    Serum creatinine not exceeding 1.7 mg/dl ( SI: ≤ 150 mmol/L)
    Platelets ≥ 100 x 103 cells/mL (SI: ≥ 100 x 109 cells/L)
    Neutrophils ≥ 1.5 x 103cells/mL (SI: ≥ 1.5 x 109 cells/L)
    8. Have met all the concomitant medication criteria in the table provided in the protocol.
    9.Subject must be intolerant to or have insufficient response from a standard therapy
    10. Are capable of providing informed consent, which must be obtained prior to any study related procedures
    E.4Principal exclusion criteria
    1. Subject with Crohn’s disease who has perianal disease and/or any active draining fistulae within the 6 months immediately preceding the screening visit
    2.Subjects with non-enterocutaneous fistulae. Subjects with healed perianal and entero-cutaneous fistulae as determined by the absence of drainage/seepage from fistula lumen following an application of clear pressure can be enrolled. In cases where determination is not possible the subject would be considered non-eligible.
    3.Subjects with Crohn’s disease that solely involves the upper GI tract
    4. Subject with abscess or suspicion of abscess
    5. Subject with symptomatic known obstructive strictures or bowel perforation in last 6 months
    6. Subject with short bowel syndrome
    7. Subject who has had a surgical bowel resection within the past 6 months or is planning any resection at time while enrolled in the study or has had 2 or more resections in total
    8. Subject with current diagnosis of Ulcerative Colitis (UC) or Indeterminant Colitis as determined by investigator or Sponsor
    9. Subject with ostomy or ileoanal pouch
    10. Subject who is currently receiving total parenteral nutrition
    11. Subject with positive stool cultures for enteric pathogens during screening (e.g. C. difficile)
    12. Previously treated in a certolizumab pegol study
    13. Subject who has received any investigational agent within 5 half-lives prior to study drug administration
    14. Subject who has received any biologic product within 12 weeks prior to screening
    15. Subject with any prior exposure to natalizumab (Tysabri)
    16. Subject with a history of drug or alcohol abuse
    17. Females who are pregnant or breast feeding
    18. Females of child bearing age or post puberty males not practicing effective birth control
    19. Subjects with a history of malignancy irrespective of time (except carcinoma –in situ of cervix or basal cell carcinoma or squamous cell carcinoma that was successfully treated)
    20. History or symptoms suggestive of lymphoproliferative disease as defined by unexplained lymphadenopathy and/or unexplained increase of white blood count of >20 x 109 cells/L
    21. History of Human Immunodeficiency Virus (HIV), chronic or active Hepatitis B or Hepatitis C
    22. History of Congestive Heart Failure (CHF), including medically controlled asymptomatic CHF
    23. Has had a opportunistic infection (e.g. cytomegalovirus, pneumoncystis carii, aspergillosis, histoplasmosis, coccidioidomycosis) within 6 months prior to screening
    24. Has had a serious infection, (e.g. pneumonia, sepsis, pyelonephritis), has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 3 months prior to screening. Less severe infections (acute upper respiratory tract infections, urinary tract infections) occurring in this timeframe need not be considered exclusionary at the discretion of the investigator and approval of the study physician. However subjects should not be enrolled when acutely ill with an intercurrent infection
    25. Has a transplanted organ (except corneal transplant)
    26. Has had a chest x-ray within 3 months prior to the first administration of study treatment that shows an abnormality suggestive of a malignancy or active infection, including TB
    27. Has received or is expecting to receive, any live virus or bacterial vaccination within 3 months of first study drug administration, during the trial or 3 months after last dose of study drug
    28. History of known demyelinating disease such as optic neuritis or multiple sclerosis
    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)
    The proportion of subjects in clinical remission (clinical remission is defined as a total Crohn’s Disease Activity Index (CDAI) score of 150 or less) at week 6
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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 Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    See Protocol
    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 months14
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 550
    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)
    Subjects enrolled into this study have the opportunity to continue into an open label extension study provided they meet the respective entry criteria.
    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 Decision2008-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-25
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