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    Summary
    EudraCT Number:2007-000734-38
    Sponsor's Protocol Code Number:104RA205
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-06-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-000734-38
    A.3Full title of the trial
    An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203
    A.4.1Sponsor's protocol code number104RA205
    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 SponsorBiogen Idec Ltd
    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.3.2Product code BG9924
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 (RA)
    MedDRA Classification
    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 determine the safety and durability of efficacy response of long-term treatment with BG9924 when administered with a stable dose of methotrexate (MTX) to subjects with rheumatoid arthritis (RA) who previously participated in Study 104RA203.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the immunogenicity of long-term treatment with BG9924 in this patient population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at Week 0:
    1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
    2. Must be a subject from Study 104RA203 who received at least 6 doses of study treatment and completed the Visit 9/Week 14/Early Withdrawal Visit or the Visit 9/Week 14 Visit and the Visit 12/Week 26/Late Withdrawal Visit in that study.
    3. Must be receiving treatment with MTX (> or =10mg/week to < or = 25mg/week) for RA, and willing to continue receiving oral folate (> or = 5mg/week) for the duration of the study.
    Note: Subjects who were unblinded (at the study site) due to a SAE in Study 104RA203 and found to be on placebo, are eligible to enroll in this study if they completed the required follow-up visit (Visit 9/Week 14/Early Withdrawal or Visit 12/Week 26/Late Withdrawal), received approval from Biogen Idec, and met all other entry criteria for this protocol.
    E.4Principal exclusion criteria
    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at Week 0:
    MEDICAL HISTORY
    1. Subjects with a history of a malignancy or carcinoma in situ (subjects with a history of excised or treated basal cell carcinoma are eligible to participate in this study).
    2. Subjects with a mole or lesion currently undiagnosed, but suspicious for malignancy. Any suspicious skin lesion should be evaluated and excised by a dermatologist prior to inclusion in the study.
    3. Subjects with a significant change (as determined by the Investigator) in medical history from their previous BG9924 study (Study 104RA203).
    4. Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including, but not limited to, vasculitis, pulmonary fibrosis, or Felty's syndrome). Secondary Sjogren's syndrome or secondary limited cutaneous vasculitis within RA is permitted.
    5. A clinically significant infectious illness or serious local infection (e.g., cellulitis, abscess) within 30 days prior to the Study Entry Visit in Study 104RA205.
    TREATMENT HISTORY
    6. Subjects who discontinued study treatment in Study 104RA203 due to any reason except disease progression.
    7. Previous treatment with any other non-TNF inhibitor biologic or prosorba column for the treatment of RA.
    8. If subjects have previously received cell-depleting therapies, relevant cell counts must have returned to within the normal range.
    9. Treatment with another investigational drug within the 3 months prior to the Week 0 or within 5 half-lives of the agent, whichever is longer.
    10. Subjects treated with the following:
    - Infliximab or adalimumab < or = 8 weeks, or etanercept < or = 4 weeks prior to Week 0.
    - Any oral steroid exceeding 10 mg/day of prednisone or equivalent within 4 weeks prior to Week 0.
    - Leflunomide < or = 8 weeks prior to Week 0.
    - Cyclosporin A < or = 6 months prior to Week 0.
    - Azathioprine or 6-MP < or = 28 days prior to Week 0.
    - Hydroxychloroquine sulfate or sulfasalazine (or equivalents), or any other allowed concomitant DMARDs, at doses greater than the recommended therapeutic dose within 4 weeks prior to Week 0.
    - Intra-articular corticosteroid injections given within 4 weeks prior to Week 0.
    11. Subjects who are planning any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) in the next 15 months, unless previously approved by Biogen Idec.
    MISCELLANEOUS
    12. Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
    13. Male and female subjects of child-bearing potential not willing to practice effective birth control for the duration of the study. Female subjects must be: (1) postmenopausal for at least 12 months, (2) surgically sterile, or (3) willing to use 2 documented forms of birth control (e.g., barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide).
    14. Current enrollment in any other investigational drug study, other than Study104RA203.
    15. Subjects who are expected to be unavailable for the duration of the study, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator/Sponsor for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to determine the safety and durability of efficacy response of long-term treatment with BG9924 when administered with a stable dose of MTX to subjects with RA who previously participated in Study 104RA203.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) No
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 Yes
    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 the study will be the date on which the last subject has his or her last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 120
    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)
    Subjects are to return to the study site for follow-up visits at Weeks 60,64 and 72.
    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 Decision2007-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-10-09
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