Clinical trial NCT00162279: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* All subjects who had completed the short term portion of IM101-101.

Primary outcomes:
measure: Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone
timeFrame: at 6 months
Secondary outcomes:
measure: ACR 50 and 70 will be evaluated
timeFrame: at 6 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Local Institution
state: Alabama
city: La Jolla
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Palo Alto
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Titusville
country: United States
facility: Local Institution
state: Florida
city: Rome
country: United States
facility: Local Institution
state: Georgia
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Hagerstown
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Duluth
country: United States
facility: Local Institution
state: Minnesota
city: Lincoln
country: United States
facility: Local Institution
state: Nebraska
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Los Alamos
country: United States
facility: Local Institution
state: New Mexico
city: Albany
country: United States
facility: Local Institution
state: New York
city: Mineola
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Bismarck
country: United States
facility: Local Institution
state: North Dakota
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Duncansville
country: United States
facility: Local Institution
state: Pennsylvania
city: Norristown
country: United States
facility: Local Institution
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Temple
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Edmonds
country: United States
facility: Local Institution
state: Washington
city: Tacoma
country: United States
facility: Local Institution
state: Washington
city: Glendale
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
References: