A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

This randomized, double-blind, parallel group study will assess the safety, disease
remission and prevention of structural joint damage on treatment with tocilizumab as
monotherapy or in combination with methotrexate, versus methotrexate in patients with early
moderate to severe rheumatoid arthritis. Patients will be randomized to receive either A)
tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or B) tocilizumab (8mg/kg iv every 4
weeks) plus methotrexate (7.5-20mg po weekly), or C) tocilizumab (4mg/kg iv every 4 weeks)
plus methotrexate (7.5-20mg po weekly), or D) placebo plus methotrexate (7.5-20mg po
weekly). Patients in groups C and D who have not achieved low disease activity at week 52
can receive tocilizumab 8mg/kg iv every 4 weeks. Anticipated time on study treatment is 104
weeks and target sample size is >1'000 individuals