Arthritis Clinical Trials

This 2 part study will investigate the safety, tolerability and efficacy of MabThera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, followed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at weeks 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional patients will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 and 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 12, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the target sample size is <100 individuals.