A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

Inclusion Criteria:

- adult patients at least 18 years of age with moderate to severe active RA for at
least 6 months;

- inadequate response to current anti-rheumatic therapies, including MTX;

- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies
within 1 year of entering study;

- on stable MTX for at least 8 weeks before entering study;

- patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

- major surgery (including joint surgery) within 8 weeks before screening, or planned
major surgery within 6 months after entering study;

- women who are pregnant or breast-feeding.