A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration
• Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)
• Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
• Autoimmune disease other than RA
• History of or current inflammatory joint disease other than RA
• Previous treatment with any biologic drug that is used in the treatment of RA
• Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
• Impaired liver, renal or hematologic function
• Active current or history of recurrent infection
• History of or currently active primary or secondary immunodeficiency