The Study of Abatacept in Combination With Etanercept

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162279
• Other study ID #: IM101-101
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 2, 2010
• Start date: October 2000
• Est. completion date: February 2007

Study information

• 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

Clinical Trial Summary

The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm