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    Summary
    EudraCT Number:2007-000830-38
    Sponsor's Protocol Code Number:C87080
    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:2008-07-21
    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 number2007-000830-38
    A.3Full title of the trial
    A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberC87080
    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 S.A. (Casa Madre)
    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.3.10 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 No
    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
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    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 continue to assess the safety of certolizumab pegol in combination with DMARD-treatment.
    E.2.2Secondary objectives of the trial
    To assess throughout the entire treatment period: Proportion of subjects in clinical remission defined as:28-joint count Disease Activity Score [DAS28-ESR] clinical Disease Activity Index [CDAI] (4) (5) Simplified Disease Activity Index [SDAI]Reduction of signs and symptoms of the disease as measured by ACR criteria Improvement in subject’s physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Relief in subject's pain, fatigue and disease activity as measured by Subject's Assessment of Arthritis Pain-VAS, Fatigue Assessment scale and Subject's Global Assessment of Disease Activity-VAS.To assess the pharmacokinetic profile and immunogenicity of certolizumab pegol in combination with DMARD(s).To assess at specific time points during the treatment period: To explore, at Week 0, subjects’ willingness to self-inject certolizumab pegol at home For subjects choosing to self-inject certolizumab pegol, to explore the burden of injection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have either failed to achieve remission at Week 20 and/or Week 24 ( CDAI>2.8), or must have achieved remission at Week 20, which was confirmed at Week 24, flared up between Week 24 and Week 52 and completed the entire C87076 study through Week 52. 2. Subjects must have complied with the protocol requirements during their participation in study C87076. 3. Female subjects of childbearing potential must have a negative urine pregnancy test at the Entry visit and must continue to have negative urine pregnancy tests administered every 8 weeks immediately before certolizumab pegol administration. Female subjects 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. Subjects must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol. 4. Subjects must be able to understand the information provided to them and to give written Informed Consent for C87080. 5. Subjects must be able and willing to comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    RA Disease Related Exclusions: 1. Subjects must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis,ankylosing spondylitis or connective tissue disease) 2. Subjects must not have a secondary, non–inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject’s primary diagnosis of RA. 3. Subjects must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ. Medical History Exclusion: 4. Female subjects who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug 5. Subjects with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection during C87076 participation (including herpes zoster), or any current sign or symptom that may indicate an infection 6. Subjects with active tuberculosis 7. Subjects at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and subjects who are permanently bed ridden or wheelchair bound) 8. Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time 9. Subjects with known concurrent acute or chronic viral hepatitis B or C. 10. Subjects with known human immunodeficiency virus (HIV) infection 11. Subjects receiving any vaccination (live or attenuated) during their participation in C87076 study. (However, influenza and pneumococcal vaccines are allowed) 12. 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). 13. Subjects with a history of blood dyscrasias 14. Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease 15. Subjects with class III or IV congestive heart failure. New York Heart Association (NYHA) 1964. 16. Subjects with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis). 17. Subjects with a history of an adverse reaction to PEG or a protein medicinal product. 18. Subjects with any other condition (e.g. clinically significant laboratory values) which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    -Efficacy Variables: Proportion of subjects in clinical remission defined as: DAS28 remission (DAS28&#8804; 2.6) by visit CDAI remission (CDAI&#8804; 2.8) by visit SDAI remission (SDAI&#8804;3.3) by visit ACR 20 (American College of Rheumatology 20% response rate), ACR 50 and ACR70 responder rate by visit Change from Baseline in HAQ–DI by visit. Change from Baseline in Subject's Assessment of Arthritis Pain-VAS, Fatigue Assessment scale and Subject's Global Assessment of Disease Activity-VAS by visit. Subjects willingness to self-inject (yes/no) at Week 0 For subjects choosing to self-inject, SIAQ PRE-Self-injection scores at Week 0 and SIAQ POST self-injection scores at Week 0, 2, 4, 6, 8, 10 and 12. For subjects not self-injecting, ISRQ score at Week 0, 2, 4, 6, 8, 10 and 12. 5.2 Pharmacokinetic and Pharmacodynamic Variables: Plasma samples for the measurement of certolizumab pegol concentrations and anti- certolizumab pegol antibodies will be collected at 24-week intervals until completion or withdrawal. - Safety Variables: Safety variables to be assessed are: Frequency, severity, nature, relationship and duration of SAEs reported by the subjects over the entire treatment period. Frequency, severity, nature, relationship and duration of AEs (including injection reactions) reported by the subjects over the entire treatment period. Physical examination abnormalities and vital signs over the entire treatment period. Blood parameters (hematology, chemistry and hepatic enzymes) and urine parameters
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    La fine dello studio e' definita come la data dell'ultima visita dell'ultimo paziente che corrisponde all'ultima visita di follow up, 12 settimane dopo l'ultima assunzione di farmaco
    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 months3
    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 months3
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 132
    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 Decision2008-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
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