A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Inclusion Criteria:

- Adult patients, ≥ years of age.

- Moderate to severe rheumatoid arthritis of ≥ 6 months duration.

- Receiving treatment on an outpatient basis.

- Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68
joint count) at screening and study start.

- On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior
to study start.

Exclusion Criteria:

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization.

- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's
Syndrome with rheumatoid arthritis is allowed.

- Functional class IV as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in Rheumatoid Arthritis.

- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or
rheumatoid arthritis before the age of 16 years.

- Prior history of or current inflammatory joint disease other than rheumatoid
arthritis.

- History of malignancy, active or recurrent infections, positive to hepatitis B
surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to
biologics, or a history of diverticular disease or other symptomatic GI conditions
that might predispose to perforations.

Other inclusion and exclusion criteria applied to the study.