At a glance
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A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)
In Brief
A Phase 3 clinical trial evaluating methotrexate, placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 77 participants across 13 sites.
Detailed 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.
Study Details
Timeline
Interventions
15-25 mg orally weekly, Weeks 1-12
15-25 mg orally weekly, Weeks 13-24
methotrexate placebo orally weekly, Weeks 13-24
8 mg/kg iv every 4 weeks, 24 weeks