An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs

This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.

Inclusion Criteria:

• Adult patients >/=18 years of age
• Moderate to severe rheumatoid arthritis defined as DAS 28>3.2
• Body weight </=150 kg
• Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
• Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion Criteria:

• Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
• Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
• Functional class IV as defined by the ACR classification
• History or current inflammatory joint disease other than RA
• Previous treatment with any cell depleting therapy
• Previous treatment with methotrexate
• Previous treatment with tocilizumab
• Previous treatment with any biologic drug that is used in the treatment of RA