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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-001913-41
    Sponsor's Protocol Code Number:C87085
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-12
    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 ConcernedItaly - Italian Medicines Agency
    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.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberC87085
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 Celletech
    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 typeequal
    D.3.10.3Concentration number150
    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 typeNon Applicabile
    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 placeboPowder for solution 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 response in subjects with moderately to severely active Crohn’s disease (CD).
    E.2.2Secondary objectives of the trial
    To assess the effect of certolizumab pegol on induction of clinical remission
    To assess the impact of certolizumab pegol on the Inflammatory Bowel Disease Questionnaire (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. Moderately to severely active Crohn’s disease (CDAI &#8805; 220 &#8804; 450) scored over the 7 days prior to the Baseline visit
    3. No previous treatment with an anti-TNF agent
    4. Male or female aged 18-75 years old
    5. Are considered eligible according to the following TB screening criteria:
    Have no history of latent or active TB prior to screening
    Have no signs or symptoms suggestive of active TB
    Have a negative PPD (TST) skin test as defined by induration less than 5 mm
    Subjects who have a positive PPD test defined as induration equal or greater than 5mm are required to commit to have prophylactic treatment with for example isonicotinic acid hydrazide (INH therapy) with vitamin B6 to prevent neuropathy, for a minimum duration of 9 months. Additional prophylactic treatment and follow-up of subjects is at the discretion of the investigator. Subjects who do not initiate prophylactic treatment for latent TB per sponsor requirement are not eligible to enter the trial. Subjects are eligible to enter the study once 30-day period on TB prophylaxis has elapsed
    All subjects should take a TB survey at visit 1 of the study (Appendix 17.4). Subjects deemed to have a high risk of latent TB are required to have TB prophylaxis initiated irrespective of PPD test result
    Have a chest x-ray taken within 3 months prior to the Baseline visit that was read by a qualified radiologist or pulmonary physician, with no evidence of current active TB or old inactive TB
    6. 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: &#8804; 150 &#61549;mol/L)
    Platelets &#8805; 100 x 103 cells/&#61549;L (SI: &#8805; 100 x 109 cells/L)
    Neutrophils &#8805; 1.5 x 103cells/&#61549;L (SI: &#8805; 1.5 x 109 cells/L)
    7. Have met all the concomitant medication criteria in the following table. For all drugs taken at screening, the subject must remain on a stable dose throughout the duration of the study.
    8. 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 known fistulae
    2. Subject with abscess or suspicion of abscess
    3. Subject with symptomatic known obstructive strictures or bowel perforation in last 6 months
    4. Subject with short bowel syndrome
    5. 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
    6. Subject with current diagnosis of Ulcerative Colitis (UC) or Indeterminant Colitis as determined by investigator or Sponsor
    7. Subject with ostomy or ileoanal pouch
    8. Subject who is currently receiving total parenteral nutrition
    9. Subject with positive stool cultures for enteric pathogens during screening (e.g. C. difficile)
    10. Previous participation in a certolizumab pegol study
    11. Subject who has received any investigational agent within 5 half-lives prior to study drug administration
    12. Subject who has received any biologic product within 12 weeks prior to screening
    13. Subject with any prior exposure to natalizumab (Tysabri)
    14. Subject with a 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 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
    19. History of Human Immunodeficiency Virus (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 (e.g. cytomegalovirus, pneumoncystis carii, aspergillosis, histoplasmosis, coccidioidomycosis) within 6 months prior to screening
    22. 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
    23. Has a transplanted organ (except corneal transplant)
    24. 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
    25. 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
    26. History of known demyelinating disease such as optic neuritis or multiple sclerosis
    27. 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)
    -
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    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 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 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 2008-02-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 250
    F.4.2.2In the whole clinical trial 500
    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 Decision2008-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-25
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