The Study of Abatacept in Combination With Etanercept
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00162279
Collaborator
(none)
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35
76
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Study Details
Study Description
Brief Summary
The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
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
Study Start Date
:
Oct 1, 2000
Actual Primary Completion Date
:
Feb 1, 2007
Actual Study Completion Date
:
Feb 1, 2007
Outcome Measures
Primary Outcome Measures
- Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone [at 6 months]
Secondary Outcome Measures
- ACR 50 and 70 will be evaluated [at 6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All subjects who had completed the short term portion of IM101-101.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Huntsville | Alabama | United States | |
| 2 | Local Institution | La Jolla | California | United States | |
| 3 | Local Institution | Long Beach | California | United States | |
| 4 | Local Institution | Los Angeles | California | United States | |
| 5 | Local Institution | Palo Alto | California | United States | |
| 6 | Local Institution | San Francisco | California | United States | |
| 7 | Local Institution | Denver | Colorado | United States | |
| 8 | Local Institution | Ft. Lauderdale | Florida | United States | |
| 9 | Local Institution | Titusville | Florida | United States | |
| 10 | Local Institution | Rome | Georgia | United States | |
| 11 | Local Institution | Chicago | Illinois | United States | |
| 12 | Local Institution | Hagerstown | Maryland | United States | |
| 13 | Local Institution | Boston | Massachusetts | United States | |
| 14 | Local Institution | Springfield | Massachusetts | United States | |
| 15 | Local Institution | Duluth | Minnesota | United States | |
| 16 | Local Institution | Lincoln | Nebraska | United States | |
| 17 | Local Institution | New Brunswick | New Jersey | United States | |
| 18 | Local Institution | Los Alamos | New Mexico | United States | |
| 19 | Local Institution | Albany | New York | United States | |
| 20 | Local Institution | Mineola | New York | United States | |
| 21 | Local Institution | New York | New York | United States | |
| 22 | Local Institution | Bismarck | North Dakota | United States | |
| 23 | Local Institution | Cincinnati | Ohio | United States | |
| 24 | Local Institution | Portland | Oregon | United States | |
| 25 | Local Institution | Duncansville | Pennsylvania | United States | |
| 26 | Local Institution | Norristown | Pennsylvania | United States | |
| 27 | Local Institution | Charleston | South Carolina | United States | |
| 28 | Local Institution | Knoxville | Tennessee | United States | |
| 29 | Local Institution | Austin | Texas | United States | |
| 30 | Local Institution | Dallas | Texas | United States | |
| 31 | Local Institution | Temple | Texas | United States | |
| 32 | Local Institution | Salt Lake City | Utah | United States | |
| 33 | Local Institution | Edmonds | Washington | United States | |
| 34 | Local Institution | Tacoma | Washington | United States | |
| 35 | Local Institution | Glendale | Wisconsin | United States |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00162279
Other Study ID Numbers:
- IM101-101
First Posted:
Sep 13, 2005
Last Update Posted:
Dec 6, 2010
Last Verified:
Dec 1, 2010