Back to resultsThe Study of Abatacept in Combination With Etanercept
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abatacept
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: All subjects who had completed the short term portion of IM101-101.
Sites / Locations
- Local Institution
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Outcomes
Primary Outcome Measures
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone
Secondary Outcome Measures
ACR 50 and 70 will be evaluated
Full Information
NCT ID
NCT00162279
First Posted
September 9, 2005
Last Updated
December 2, 2010
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00162279
Brief Title
The Study of Abatacept in Combination With Etanercept
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
141 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Abatacept
Primary Outcome Measure Information:
Title
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
ACR 50 and 70 will be evaluated
Time Frame
at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects who had completed the short term portion of IM101-101.
Facility Information:
Facility Name
Local Institution
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
La Jolla
State/Province
California
Country
United States
Facility Name
Local Institution
City
Long Beach
State/Province
California
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Institution
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Local Institution
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Titusville
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Rome
State/Province
Georgia
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Duluth
State/Province
Minnesota
Country
United States
Facility Name
Local Institution
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Local Institution
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Los Alamos
State/Province
New Mexico
Country
United States
Facility Name
Local Institution
City
Albany
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Mineola
State/Province
New York
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
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Local Institution
City
Bismarck
State/Province
North Dakota
Country
United States
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Local Institution
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Cincinnati
State/Province
Ohio
Country
United States
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Local Institution
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Portland
State/Province
Oregon
Country
United States
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Local Institution
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Temple
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Local Institution
City
Edmonds
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Glendale
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
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The Study of Abatacept in Combination With Etanercept
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