A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Inclusion Criteria:

- Adult patients, ≥ 18 to < 65 years of age

- Rheumatoid Arthritis (RA) of > 6 months duration at baseline (American College of
Rheumatology criteria)

- Willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid
adsorbed vaccines

- Previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years
of baseline, with tetanus containing vaccine ≥ 5 years

- Methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25
mg/week (oral or parenteral)

- Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before
baseline

- Oral corticosteroids must be at stable dose of < 10 mg/day prednisone or equivalent

- Body weight ≤ 150 kg at screening

Exclusion Criteria:

- Major surgery (including joint surgery) within 12 weeks prior to baseline or planned
major surgery within 8 weeks after baseline

- History of or current inflammatory joint disease or rheumatic autoimmune disease
other than RA

- Pre-existing central nervous system demyelinating or seizure disorders

- Active current or history of recurrent bacterial, viral fungal, mycobacterial and
other infections

- Any major episode of infection requiring hospitalization or treatment with
intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2
weeks prior to baseline

- Active tuberculosis requiring treatment within 3 years prior to baseline

- Primary or secondary immunodeficiency (history or currently active)

- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

- Previous treatment with RoActemra/Actemra