Conditions: Arthritis, Rheumatoid
Keywords: Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine Sirukumab Human Anti-IL-6 Monoclonal Antibody
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).

Detailed description:
This is a randomized (patients will be assigned to treatment by chance), double-blind (study personnel and patients will not know what treatments are being given), multicenter study. The expected duration of the study is 68 weeks. This will include 52 weeks of treatment with study agent with dosing every 2 weeks and 16 weeks of safety follow-up after the last dose. Disease-modifying antirheumatic drugs (DMARDs), including MTX and SSZ, are not permitted from 4 weeks before the first dosing with study agent until Week 24. The use of DMARDs is discouraged at or any time after Week 24; however, patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 24 will be allowed to take DMARDs. At or any time after Week 16, the initiation and/or adjustment of oral corticosteroids will be allowed for patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 16.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sirukumab 100 mg intervention 2: Sirukumab 50 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52. intervention 2: Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. intervention 3: Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.

Protocol document: