Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

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: 15-25 mg orally weekly, Weeks 1-12 intervention 2: 15-25 mg orally weekly, Weeks 13-24 intervention 3: methotrexate placebo orally weekly, Weeks 13-24 intervention 4: 8 mg/kg iv every 4 weeks, 24 weeks

Protocol document: