A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

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

This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

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• Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline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