A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug
Days 1-169
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
IM101-064
NCT00124982
April 2005
August 2009
Name | Location |
---|---|
Local Institution | Chicago, Illinois |
Local Institution | Indianapolis, Indiana |
Local Institution | Bronx, New York |
Local Institution | Cincinnati, Ohio |
Local Institution | Portland, Oregon |
Local Institution | Vancouver, Washington |
Local Institution | Green Bay, Wisconsin |
Local Institution | Birmingham, Alabama |
Local Institution | Phoenix, Arizona |
Local Institution | Corona, California |
Local Institution | Aurora, Colorado |
Local Institution | Hamden, Connecticut |
Local Institution | Washington, District of Columbia |
Local Institution | Fort Lauderdale, Florida |
Local Institution | Wichita, Kansas |
Local Institution | Springfield, Massachusetts |
Local Institution | Duluth, Minnesota |
Local Institution | Lincoln, Nebraska |
Local Institution | New Brunswick, New Jersey |
Local Institution | Wilmington, North Carolina |
Local Institution | Duncansville, Pennsylvania |
Local Institution | North Charleston, South Carolina |
Local Institution | Austin, Texas |
Local Institution | Arlington, Virginia |
Local Institution | Rome, Georgia |
Local Institution | New Orleans, Louisiana |
Local Institution | Bismarck, North Dakota |
Local Institution | Providence, Rhode Island |
Local Institution | Chattanooga, Tennessee |
Local Institution | Iowa City, Iowa |
Local Institution | Louisville, Kentucky |
Local Institution | Detroit, Michigan |
Local Institution | Las Vegas, Nevada |
Local Institution | Lebanon, New Hampshire |
Local Institution | Sioux Falls, South Dakota |