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.
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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- Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before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
Anniston, Alabama 36207, United States
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