A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Rheumatoid arthritis of >/= 1 year duration
• Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
• On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
• Body weight </= 150 kg
• Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
• Rheumatic autoimmune disease other than rheumatoid arthritis
• Functional class IV American College of Rheumatology (ACR) Classification
• Prior history of or current inflammatory joint disease other than rheumatoid arthritis
• Treatment with a biologic agent at any time prior to baseline
• Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• Previous treatment with tocilizumab
• Pregnant or lactating women
• Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
• Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
• History of or currently active primary or secondary immunodeficiency
• Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
• Active tuberculosis requiring treatment within the previous 3 years
• Positive for HIV infection