A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Inclusion Criteria:

• Adult patients, over the age of 18 years
• Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
• DAS28 >3.2
• Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6 (68 joint count)
• Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
• Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
• Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
• Prior history of or current inflammatory joint disease other than RA