A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs

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.

Inclusion Criteria:

• adult patients, >/=18 years of age
• moderate to severe rheumatoid arthritis of >/=6 months duration
• synovitis (swollen and tender joint) in the wrist of the dominant hand
• non-biologic DMARDs at stable dose for >/=12 weeks prior to baseline
• oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

• rheumatic autoimmune disease other than RA
• history of or current inflammatory joint disease other than RA
• functional class IV (ACR classification)
• intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• previous treatment with a biologic agent for RA