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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-005288-86
    Sponsor's Protocol Code Number:C87077
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005288-86
    A.3Full title of the trial
    A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis
    A.4.1Sponsor's protocol code numberC87077
    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 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.3.9.3Other 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 typeequal
    D.3.10.3Concentration number200
    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
    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
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 two dose regimens of certolizumab pegol (200 mg administered Q2W and 400 mg administered Q4W) in combination with MTX as compared to MTX alone for maintenance of clinical response over an additional 16 weeks in patients who have responded (i.e. achieved ACR20) to the initial 18-weeks of treatment (certolizumab pegol 400mg at Weeks 0, 2 and 4 followed by 200 mg certolizumab pegol and placebo at Weeks 6, 8, 10, 12, 14 and 16 plus MTX).
    E.2.2Secondary objectives of the trial
    All patients, to assess at week 16:
    - clinical response rate
    - reduction of disease activity
    - achievement of clinical remission
    - improvement in physical function
    To evaluate tolerability and safety of CZP therapy in patients with active RA on a stable dose of concomitant MTX therapy

    In patients randomized at Week 18, to assess at week 34:
    - clinical response rate
    - reduction of disease activity
    - achievement of clinical remission
    - improvement in physical function
    - reduction in fatigue
    - improvement in
    - patient’s Health-Related Quality of Life
    - arthritis pain
    - disease activity
    To assess the time to loss of ACR20 response (at 2 consecutive visits) after Week 18

    Exploratory Objectives:
    To explore:
    - pharmacokinetic profile and immunogenicity of the different dose regimens.
    - impact of CZP therapy on patient’s height, used as a surrogate endpoint for bone strength.
    - impact of CZP therapy on the patient’s lipid profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be at least 18 years old at the screening visit.
    2. Patients must be able to understand the information provided to them and to give written Informed Consent.
    3. Female patients must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol. Male patients must agree to ensure they or their female partner(s) uses adequate contraception during the study and for 12 weeks after the patient receives their last dose of certolizumab pegol.
    4. Patients must have a diagnosis of adult–onset RA of at least six months duration but not longer than fifteen years as defined by the 1987 American College of Rheumatology classification criteria.
    5. Patients must be rheumatoid factor positive and/or anti-CCP positive.
    6. Patients must have active RA disease as defined by:
    • ≥6 tender joints (28 joint count) at Screening and Baseline; and
    • ≥4 swollen joints (28 joint count) at Screening and Baseline; and
    • ≥10 mg/L (>1 mg/dL) CRP AND/OR > 28mm/hour ESR (Westergren)
    7. Patients must have received treatment with MTX (10-25 mg/week, with or without folic acid) for at least three months prior to the Baseline visit. The dose of MTX and route of administration must have been stable for at least 2 months prior to the Baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
    8. Patients must be able and willing to comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    1. Patients must not have a diagnosis of any other inflammatory arthritis
    2. Patients must not have a secondary, non–inflammatory type of arthritis that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient’s primary diagnosis of RA.
    3. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
    4. Patients must be free of prohibited medication as detailed in the protocol.
    5. Patients must not have received any experimental non–biological therapy, within or outside of a clinical trial in the three months prior to Baseline visit.
    6. Patients must not have received any experimental biological agent in the past three months or within 5 half-lives prior to Baseline (whichever is longer).
    7. Patients must not have received any biological therapy for RA within three months prior to Baseline visit, except for etanercept or anakinra for which a one month washout prior to Baseline visit is acceptable.
    8. Patients must not have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.
    9. Patients who failed to respond to previous treatment with an anti–TNF drug (i.e., primary failures) are excluded. Patients who initially responded to a previous treatment with an anti-TNF drug but who later discontinued that drug due to loss of efficacy or financial or other reasons (other than severe hypersensitivity reaction or an anaphylactic reaction) may be included.
    10. Female patients who are breast-feeding, pregnant, or plan to become pregnant during the trial or within three months following last dose of study drug.
    11. Patients with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.
    12. Patients with active TB (or history of active TB), positive chest X–ray for TB, or positive PPD skin test (defined as induration of ≥ 5mm) or patients having close contact with an individual with active TB. Patients having PPD skin test ≥ 5mm can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent tuberculosis and provided that treatment is initiated at least 1 month prior to first administration of certolizumab pegol.
    13. Patients at a high risk of infection (e.g., the presence of leg ulcers or an indwelling urinary catheter, persistent or recurrent chest infections, or patients who are permanently bedridden or wheelchair bound).
    14. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
    15. Patients with concurrent acute or chronic viral hepatitis B or C.
    16. Patients with known human immunodeficiency virus (HIV) infection.
    17. Patients receiving any vaccination (live or attenuated) within eight weeks prior to Baseline (e.g., inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted).
    18. 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).
    19. Patients with a history of blood dyscrasias.
    20. Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological,gastrointestinal, endocrine, pulmonary, cardiac (e.g. ischemic heart disease, heart failure and rhythm disorders), neurological or cerebral disease (e.g. stroke).
    21. Patients with class III or IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria.
    22. Patients with a history of, or suspected, demyelinating disease of the central nervous system.
    23. Patients with a history of an adverse reaction to PEG.
    24. Patients with any other condition (e.g., clinically significant laboratory values) which in the Investigator’s judgment would make the patient unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the ACR20 responder rate at Week 34 (V19) in the patients randomized at Week 18.

    Secondary Efficacy Variables
    All patients, at week 16:
    - ACR20, ACR50 and ACR70 responder rate
    - Change from Baseline in DAS28, SDAI and CDAI scores
    - DAS28 remission (<2.6) rate, SDAI remission (≤3.3) rate and CDAI remission (≤2.8) rate
    - Change from Baseline in HAQ–DI

    In the patients randomized at Week 18,
    at week 34:
    - ACR50 and ACR70 responder rate
    - Change from Baseline in DAS 28, SDAI and CDAI scores
    - DAS28 remission (<2.6) rate, SDAI remission (≤3.3) rate and CDAI remission (≤2.8) rate
    - Change from Baseline in HAQ–DI
    - Change from Baseline in the Fatigue Assessment Scale
    - Change from Baseline in SF-36 domains as well as Mental and Physical Component Summary score (MCS and PCS)
    - Change from Baseline in the Patient’s Assessment of Arthritis Pain-VAS
    - Change from Baseline in the Patient’s Global Assessment of Disease Activity-VAS
    The time to loss of ACR20 response (at 2 consecutive visits) after week 18

    Pharmacokinetic and Pharmacodynamic Variables:
    Plasma samples for the measurement of certolizumab pegol concentrations and anti- certolizumab pegol antibodies will be collected at Baseline and Weeks 16, 28 and 34.

    Safety variables to be assessed are adverse events, vital signs, physical examination, including symptoms of active tuberculosis, and measurements of laboratory parameters.

    Clinical laboratory values (hematology, biochemistry and urinalysis) will be collected and assessed.
    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 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 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) 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 Yes
    E.8.1.7.1Other trial design description
    the run-in period is open-label
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    The end of study is defined as the date of Last Patient Last Visit (i.e. last patient completing the 12 week safety follow-up visit)
    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 months9
    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 months9
    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 Information not present in EudraCT
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 335
    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)
    Please refer to sections 11.2.19 and 11.2.20 in protocol
    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 Decision2009-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-01
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