Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 261
Healthy volunteers: no

Brief summary:
This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: methotrexate intervention 2: methotrexate intervention 3: placebo intervention 4: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: orally, Week 1 - 16 intervention 2: orally, Week 17-28 intervention 3: methotrexate placebo orally, Week 17-28 intervention 4: 8 mg/kg iv every 4 weeks, 28 weeks

Protocol document: