A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Inclusion Criteria:

• adult patients, >/= 18 years of age
• moderate to severe active rheumatoid arthritis of >/=6 months duration
• inadequate clinical response to current non-biologic DMARDs
• current DMARDs must be at stable dose for 8 weeks prior to study entry
• oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening

Exclusion Criteria:

• rheumatic autoimmune disease other than RA
• history of or current inflammatory joint disease other than RA
• previous treatment with any biologic DMARD
• functional class IV as defined by the ACR classification
• intra-articular or parenteral corticosteroids within 6 weeks prior to screening