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    Summary
    EudraCT Number:2005-004104-37
    Sponsor's Protocol Code Number:C87042
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-004104-37
    A.3Full title of the trial
    A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab.
    A.4.1Sponsor's protocol code numberC87042
    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 Information not present in EudraCT
    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.3.9.2Current 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 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 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 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
    Patients with Crohn's Disease with prior loss of response or intolerance to infliximab
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10011401
    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 subcutaneous certolizumab pegol 400mg at week 6, following administration at 0,2 and 4 weeks for the treatment of signs and symptoms of active Crohn’s disease (CDAI between 220 and 450 inclusive: scored over 7 days before the first administration of the study drug) in patients who have previously received and responded to infliximab, but who no longer have a sustained response and/ or tolerance to infliximab.
    E.2.2Secondary objectives of the trial
    - To assess and compare the clinical efficacy of subcutaneous certolizumab pegol 400mg maintenance therapy administered Q4W or Q2W over 26 weeks in patients with Crohn’s disease who responded to certolizumab pegol induction therapy.

    - To assess the clinical efficacy of subcutaneous certolizumab pegol 400 mg as induction and two regimens of maintenance therapy on patient reported outcome scores.

    - To evaluate tolerability and safety of certolizumab pegol induction and maintenance therapy in patients who have previously received and responded to infliximab, but who no longer have a sustained response and/ or have tolerance to infliximab.

    - To evaluate the effect of certolizumab pegol induction and maintenance therapy on plasma CRP levels.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Adult men and women ≥ 18 years

    Patient suffering from Crohn’s disease with a CDAI score between 220 and 450, scored over the 7 days prior to the first study treatment dose.

    Patients must have been treated and must have responded to infliximab (estimated by the Investigator and documented by the patient’s medical file) but are no longer responding or have developed intolerability due to acute or delayed infusion reactions.

    Loss of response is defined as: No response or lack of improvement/ worsening of the clinical symptoms (liquid stools, abdominal pain, fever, drainage of existing fistulas or development of new fistulas, rectal bleeding, changing or introduction of new anti diarrheic medication) after two consecutive infusions of infliximab of at least 5mg/kg with a maximum interval of 8 weeks evaluated two weeks after the last infusion.

    Acute infusion reactions to infliximab include at least one of the following signs or symptoms during or within 2 hours of the infliximab infusion:- hypotension- urticaria- flushing- facial or hand edema,- throat tightness, oral cavity or lip edema- headache- shortness of breath.

    Delayed infusion reactions to infliximab are defined as at least two of the following four signs or symptoms occurring within 1-14 days following the infliximab infusion:- rash- fever (more than 100° F (38° C)- polyarthralgias- myalgias.

    Patients able to understand the information provided to them and to give written informed consent.

    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; 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 CDP870.

    Concomitant medications5-ASA or antibiotics (stable for 4 weeks prior screening), corticosteroids equivalent to or less than 30 mg prednisone per day (stable dose for 2 weeks), azathioprine and 6-mercaptopurine or methotrexate (stable dose for 8 weeks) are allowed at Baseline and during the study. Tapering of the dose of steroids is allowed after week 8 starting with 5 mg weekly if the dose higher than 20mg/ daily and with 2.5 mg weekly onward until the complete discontinuation of steroids. The patients taking 20mg/day or less will start directly to taper with 2,5 mg weekly.
    E.4Principal exclusion criteria
    Crohn’s Disease Related:

    Symptomatic obstructive intestinal strictures. Bowel resection within 4 weeks of starting the study medication. Fistula abscess present at screening. Current total parenteral 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 pregnant 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 CDP870 administration.
    - 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 per local medical practice) PPD skin test.
    - A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
    - 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, HCVRNA, anti HCV antibodies with decompensated liver function will not be enrolled in the study·
    - 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, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
    - Known human immunodeficiency virus (HIV) infection.
    - New York Heart Association (NYHA) class III-IV congestive heart failure requiring medical treatment.
    - A history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).·
    - A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product.
    - Any other condition, which in the Investigator’s judgment would make the patient unsuitable for inclusion in the study

    Previous clinical trials and previous biological therapy exclusion:
    - Receipt of any experimental biological or non-biological therapy within or outside a clinical trial in the 3 months prior to Baseline visit.
    - Patients treated with infliximab within 12 weeks prior to screening.
    - Previous treatment with a biological therapy for CD (including CDP870) that resulted in a severe hypersensitivity reaction, an anaphylactic reaction or lack of response**Patients having experienced severe or anaphylactic reactions only will not be enrolled

    Concomitant medications exclusion criteria
    - 5-ASA or antibiotics (stable for 4 weeks prior screening), corticosteroids equivalent to or less than 30 mg prednisone per day (stable dose for 2 weeks), azathioprine and 6-mercaptopurine or methotrexate (stable dose for 8 weeks) are allowed at Baseline and during the study.
    - Any modification in the concomitant treatments (dose and/or frequency), other than those described above will be considered as non authorized concomitant medication.· Other biological therapy will be prohibited throughout the study.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate with response defined as at least 100 point decrease of CDAI score from baseline at week 6.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    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.8.5The 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 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 Information not present in EudraCT
    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 study is defined as the date of database lock as, at that time, interactions between the Sponsor and the Investigator(s) with possible impact on subject’s data have ended.
    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 months2
    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 months2
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 2006-05-11. 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 600
    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)
    Possibility of open label study until MAA approval received.
    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 Decision2006-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-01
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