Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid Active rheumatoid arthritis despite anti-TNF-alpha therapy Sirukumab Human Anti-IL-6 monoclonal antibody
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 878
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

Detailed description:
Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 68 weeks, which includes 52 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long term extension study if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 24, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

Arms:
arm 1: Patients will receive placebo every 2 weeks from Week 0 through Week 22, followed by a subcutaneous (SC) sirukumab dose regimen every 2 weeks through Week 52. arm 2: Patients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52. arm 3: Patients will receive sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC administrations will be made at Weeks 2, 6, and every 4 weeks through Week 52.

Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: Sirukumab intervention 4: Sirukumab intervention 5: Sirukumab
Intervention descriptions: intervention 1: Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22. intervention 2: Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52. intervention 3: Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52. intervention 4: Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52. intervention 5: Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

Protocol document: