Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline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
You may not be if
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
