Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 401
Healthy volunteers: no

Brief summary:
This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and an inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients will receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve sustained clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained clinical remission but achieve low disease activity (DAS-ESR \</= 3.2) will continue the initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: DMARD intervention 2: methotrexate intervention 3: tocilizumab [RoActemra/Actemra] intervention 4: tocilizumab [RoActemra/Actemra] intervention 5: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: non-biological disease-modifying antirheumatic drugs at stable dose intervention 2: stable dose intervention 3: 162 mg subcutaneously (SC) qw, Weeks 1-24 intervention 4: 162 mg SC qw or q2w, Weeks 24-48 intervention 5: 162 mg SC qw, Weeks 24-48

Protocol document: