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    Summary
    EudraCT Number:2007-000828-40
    Sponsor's Protocol Code Number:C87076
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-12
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-000828-40
    A.3Full title of the trial
    A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNF╬▒ Fab′fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis.
    A.4.1Sponsor's protocol code numberC87076
    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.3.9.2Current 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 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 certolizumab pegol as an add-on therapy in demonstrating clinical remission at both Week 20 and Week 24 (defined as Clinical Disease Activity Index [CDAI] of ≤ 2.8).
    E.2.2Secondary objectives of the trial
    To compare the efficacy of the two treatment arms in:
    - Achievement of clinical remission at both Week 20 and Week 24.
    - Maintenance of remission between Week 24 and Week 52.
    - Reduction of signs and symptoms of the disease at Week 24 as measured by ACR
    criteria.
    - Improvement in patient’s physical function as measured by the HAQ-DI at Weeks 24.
    - Improvement in patient’s Health-Related Quality of Life as measured by the SF-36 Physical and Mental Component Summary scores (PCS and MCS, respectively) and SF-36 domains at Weeks 24.
    - Relief in patient's pain, fatigue and disease activity as measured by Patient’s
    Assessment of Arthritis Pain-VAS, Fatigue Assessment scale and Patient’s Global Assessment of Disease Activity -VAS at Week 24.
    - To evaluate the tolerability and safety of certolizumab pegol therapy.
    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. Female patients must be either postmenopausal for at least one year, surgically
    incapable of childbearing, or effectively practicing an acceptable method of
    contraception (i.e. 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.
    3. Patients must have a diagnosis of adult–onset RA (of at least six months duration but not longer than ten years) as defined by the 1987 American College of Rheumatology classification criteria.
    4. Patients must have moderate to low disease activity as defined by all of the following:
    • CDAI > 6 and ≤ 16 at Screening and Baseline
    • ≥ 2 tender joints (28 joint count) at Screening and Baseline
    • ≥ 2 swollen joints (28 joint count) at Screening and Baseline
    • fulfilling 1 of the following 2 criteria during the screening period:
    • ≥28 mm/hour ESR (Westergren), or
    • CRP >10 mg/L
    5. Patients must have received combination or mono DMARD therapy ((i.e., Sulfasalazine ≤ 3mg/day; Leflunomide ≤ 20mg/day; Hydroxychloroquine ≤400mg/day; MTX ≤ 25mg/week) for at least six months prior to the Baseline visit.
    The dose and route of administration of the DMARD therapy must have been stable
    for at least 2 months prior to the baseline visit.
    6. Patients must be able to understand the information provided to them and to give
    written Informed Consent.
    7. 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 (e.g., psoriatic arthritis,ankylosing spondylitis or connective tissue disease).
    2. Patients 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 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 respective table in the protocol.
    5. Patients must not have received any previous biological therapy for RA.
    6. Patients must not have received any experimental non–biological therapy, within or outside a clinical trial in the three months prior to Baseline visit.
    7. Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
    8. 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.
    9. Patients with active TB (or history of active TB) or positive chest X–ray for TB or
    positive (defined as induration of ≥ 5mm) PPD skin test or patients having close
    contact with an individual with active TB. Patients having a PPD skin test greater or
    equal to 5 mm can enter the study, provided that active TB is excluded and provided
    that they are adequately treated for latent tuberculosis (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that treatment is initiated at least 1 month prior to first administration of certolizumab pegol.
    10. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and
    persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).
    11. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
    12. Patients with known concurrent acute or chronic viral hepatitis B or C.
    13. Patients with known human immunodeficiency virus (HIV) infection.
    14. Patients receiving any vaccination (live or attenuated) within eight weeks prior to
    Baseline. (However, influenza and pneumococcal vaccines are allowed)
    15. 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).
    16. Patients with a history of blood dyscrasias.
    17. Patients 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.
    18. Patients with class III or IV congestive heart failure. New York Heart Association
    (NYHA) 1964.
    19. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
    20. Patients with a history of an adverse reaction to PEG or a protein medicinal product.
    21. Patients with any other condition (i.e. 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 proportion of subjects in CDAI remission (CDAI
    ≤ 2.8) at both Week 20 and Week 24 visits.

    The secondary efficacy variables are:
    • Proportion of subjects in DAS28 remission (DAS28 < 2.6) at both Week 20 and Week 24 visits.
    • Proportion of subjects in SDAI remission (SDAI≤3.3) at both Week 20 and Week 24
    visits.
    • Time from stopping treatment (Week 24 visit) to loss of remission. This analysis will
    be done defining loss of remission as CDAI>2.8 at two consecutive visits. The same
    analysis will be redone twice: once basing loss of remission on SDAI >3.3 at two
    consecutive visits and once DAS28 ≥ 2.6 at two consecutive visits
    • ACR20 (American College of Rheumatology 20% response criteria), ACR50 and
    ACR70 responder rate at Week 24 visit.
    • Change from baseline in HAQ–DI at Week 24.
    • Change from baseline in SF–36 PCS and MCS and SF-36 domains at Week 24.
    • Change from baseline in Patient's Assessment of Arthritis Pain-VAS, Fatigue
    Assessment Scale and Patient's Global Assessment of Disease Activity-VAS at Week
    24.

    Pharmacokinetic and Pharmacodynamic Variables:
    Plasma samples for the measurement of certolizumab pegol concentrations and anti- certolizumab pegol antibodies will be collected

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

    Clinical laboratory values (hematology, biochemistry and urinalysis), ESR and CRP will be collected.
    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 No
    E.6.10Pharmacogenetic No
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    The end of study is defined as the date of Last Patient Last Visit, i.e., Week 62 (follow-up visit 12 weeks post-dose).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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 state91
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 11.2.26 and 11.2.27 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 Decision2009-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-10
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