To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
226
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
2 injections Day 1, 1 injection Days 15 and 29
40 mg adalimumab every other week
Blood samples for Influenza A & B antibody Assay
Time frame: Baseline (Day 1), Day 36 or premature discontinuation
Blood Samples for Pneumococcal Antibody Assay
Time frame: Baseline (Day 1), Day 36 or premature discontinuation
Laboratory assessments
Time frame: Screening, Week 15, Day 36, Month 3 and Month 6
Vitals signs
Time frame: Screening - Month 6
Adverse events
Time frame: Screening - Month 6
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