A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)

This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
• Inadequate response to DMARDs
• Body weight < 150 kg

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
• Rheumatic autoimmune disease other than RA
• American College of Rheumatology (ACR) functional class IV
• Prior history of or current inflammatory joint disease other than RA
• Previous treatment with any biologic drug that is used in the treatment of RA
• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• Pregnant or lactating women
• Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection