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

Inclusion Criteria:

• Adult patients ≥ 18 years of age.

• Rheumatoid arthritis of ≤ 2 years duration.

• Disease Activity Score 28 (DAS28) > 3.2.

• Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.

• Rheumatoid factor (RF) and/or anti−cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative > 1 erosion required at screening).

• Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/Lat screening.

Exclusion Criteria:

• Previous treatment with tocilizumab.

• Previous treatment with methotrexate or biologic agent.

• Rheumatic autoimmune disease other than rheumatoid arthritis (RA).

• History of or current inflammatory joint disease other than RA.

• Functional class IV as defined by the American College of Rheumatology (ACR)Classification of Functional Status in RA.