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
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes
Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels. The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.
Baseline (Week 3) and Week 8 (5 weeks post-vaccination)
No
Micki Klearman, M.D.
Study Director
Genentech
United States: Food and Drug Administration
NA25256
NCT01163747
September 2010
June 2012
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Little Rock, Arkansas 72205-7199 | |
Hackensack, New Jersey 07601 | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Charleston, West Virginia 25304 | |
Las Vegas, Nevada 89109 | |
Jackson, Mississippi | |
Coeur D'alene, Idaho 83814 |