The Study of Abatacept in Combination With Etanercept
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
1 other identifier
interventional
141
1 country
35
Brief Summary
The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Oct 2000
Longer than P75 for phase_2 rheumatoid-arthritis
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 6, 2010
December 1, 2010
6.3 years
September 9, 2005
December 2, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone
at 6 months
Secondary Outcomes (1)
ACR 50 and 70 will be evaluated
at 6 months
Interventions
Eligibility Criteria
You may qualify if:
- All subjects who had completed the short term portion of IM101-101.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Local Institution
Huntsville, Alabama, United States
Local Institution
La Jolla, California, United States
Local Institution
Long Beach, California, United States
Local Institution
Los Angeles, California, United States
Local Institution
Palo Alto, California, United States
Local Institution
San Francisco, California, United States
Local Institution
Denver, Colorado, United States
Local Institution
Fort Lauderdale, Florida, United States
Local Institution
Titusville, Florida, United States
Local Institution
Rome, Georgia, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Hagerstown, Maryland, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
Local Institution
Duluth, Minnesota, United States
Local Institution
Lincoln, Nebraska, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Los Alamos, New Mexico, United States
Local Institution
Albany, New York, United States
Local Institution
Mineola, New York, United States
Local Institution
New York, New York, United States
Local Institution
Bismarck, North Dakota, United States
Local Institution
Cincinnati, Ohio, United States
Local Institution
Portland, Oregon, United States
Local Institution
Duncansville, Pennsylvania, United States
Local Institution
Norristown, Pennsylvania, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
Knoxville, Tennessee, United States
Local Institution
Austin, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Temple, Texas, United States
Local Institution
Salt Lake City, Utah, United States
Local Institution
Edmonds, Washington, United States
Local Institution
Tacoma, Washington, United States
Local Institution
Glendale, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
October 1, 2000
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
December 6, 2010
Record last verified: 2010-12