Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy

The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment

Inclusion Criteria:

• adult patients, >= 18 years of age
• Active RA of > 6monts duration
• Received permitted DMARDs each at a stable dose for at least 8 weeks

Exclusion Criteria:

• Rheumatic autoimmune disease other than RA
• Significant systemic involvement secondary to RA
• ALT or AST > ULNⅹ1.5
• Platelet count < 100,000/mm3
• Hemoglobin < 8.5 g/dL
• White blood cells < 3,000/mm3
• Absolute neutrophil count < 2,000/mm3
• Absolute lymphocyte count < 500/mm3