Rheumatoid Arthritis Clinical Trial
Official title:
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis
Verified date | December 2010 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
Status | Completed |
Enrollment | 141 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All subjects who had completed the short term portion of IM101-101. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Local Institution | Albany | New York |
United States | Local Institution | Austin | Texas |
United States | Local Institution | Bismarck | North Dakota |
United States | Local Institution | Boston | Massachusetts |
United States | Local Institution | Charleston | South Carolina |
United States | Local Institution | Chicago | Illinois |
United States | Local Institution | Cincinnati | Ohio |
United States | Local Institution | Dallas | Texas |
United States | Local Institution | Denver | Colorado |
United States | Local Institution | Duluth | Minnesota |
United States | Local Institution | Duncansville | Pennsylvania |
United States | Local Institution | Edmonds | Washington |
United States | Local Institution | Ft. Lauderdale | Florida |
United States | Local Institution | Glendale | Wisconsin |
United States | Local Institution | Hagerstown | Maryland |
United States | Local Institution | Huntsville | Alabama |
United States | Local Institution | Knoxville | Tennessee |
United States | Local Institution | La Jolla | California |
United States | Local Institution | Lincoln | Nebraska |
United States | Local Institution | Long Beach | California |
United States | Local Institution | Los Alamos | New Mexico |
United States | Local Institution | Los Angeles | California |
United States | Local Institution | Mineola | New York |
United States | Local Institution | New Brunswick | New Jersey |
United States | Local Institution | New York | New York |
United States | Local Institution | Norristown | Pennsylvania |
United States | Local Institution | Palo Alto | California |
United States | Local Institution | Portland | Oregon |
United States | Local Institution | Rome | Georgia |
United States | Local Institution | Salt Lake City | Utah |
United States | Local Institution | San Francisco | California |
United States | Local Institution | Springfield | Massachusetts |
United States | Local Institution | Tacoma | Washington |
United States | Local Institution | Temple | Texas |
United States | Local Institution | Titusville | Florida |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone | at 6 months | ||
Secondary | ACR 50 and 70 will be evaluated | at 6 months |
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