A Phase 2B, Blinded 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 104RA202

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

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 104RA202 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 104RA202 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 subject inclusion in the study.
3. Subjects with a significant change (as determined by the Investigator) in medical history from their previous BG9924 study (Study 104RA202).
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 104RA204.
TREATMENT HISTORY
6. Subjects who discontinued study treatment in Study 104RA202 due to any reason except disease progression.
7. Previous treatment with anti-TNF therapy or 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:
· 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 Study104RA202.
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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