Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: no

Brief summary:
This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: placebo intervention 3: non-biological DMARDs
Intervention descriptions: intervention 1: 8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks intervention 2: iv every 4 weeks for 24 weeks intervention 3: stable dose at investigator's prescription

Protocol document: