Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab versus Tocilizumab plus Non-biologic disease modifying antirheumatic drugs in Patients with Active Rheumatoid Arthritis

This phase IIIb study will include adult patients, 18 years or older,body weight 150kg or less, with moderate to severe active rheumatoid arthritis (RA) of duration 6 months or more, who are inadequate responders to DMARDs or anti-TNF therapies. The primary objective is to assess the safety and tolerability of tocilizumab (TCZ) monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). The secondary objectives is to assess the efficacy of TCZ monotherapy or in combination with non-biologic DMARDs. The study is designed so that patients would be on the study for 24 weeks, receiving 6 x 60min infusions of TCZ every 4 weeks. AEs and other safety variables will be analyzed using descriptive statistics. Safety and study data will be collected on an electronic CRF.