A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab; methotrexate; 23-Valent Pneumococcal Polysaccharide Vaccine; Tetanus Toxoid Adsorbed Vaccine
Intervention description: Intravenous repeating dose; A stable dose of between 7.5 and 25 mg/week, oral or parenteral.; Intramuscular or subcutaneous injection; Intramuscular injection
Intervention MeSH terms: Methotrexate; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

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          -  Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline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