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The Study of Abatacept in Combination With Etanercept

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162279
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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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
Rheumatoid Arthritis Drug: Abatacept Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 141 participants
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 : October 2000
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. ACR 50 and 70 will be evaluated [ Time Frame: at 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects who had completed the short term portion of IM101-101.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162279


Locations
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United States, Alabama
Local Institution
Huntsville, Alabama, United States
United States, California
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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San Francisco, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Florida
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Ft. Lauderdale, Florida, United States
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Titusville, Florida, United States
United States, Georgia
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Rome, Georgia, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Maryland
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Hagerstown, Maryland, United States
United States, Massachusetts
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
United States, Minnesota
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Duluth, Minnesota, United States
United States, Nebraska
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Lincoln, Nebraska, United States
United States, New Jersey
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New Brunswick, New Jersey, United States
United States, New Mexico
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Los Alamos, New Mexico, United States
United States, New York
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Albany, New York, United States
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Mineola, New York, United States
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New York, New York, United States
United States, North Dakota
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Bismarck, North Dakota, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Oregon
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Portland, Oregon, United States
United States, Pennsylvania
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Duncansville, Pennsylvania, United States
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Norristown, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
United States, Tennessee
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Knoxville, Tennessee, United States
United States, Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Temple, Texas, United States
United States, Utah
Local Institution
Salt Lake City, Utah, United States
United States, Washington
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Edmonds, Washington, United States
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Tacoma, Washington, United States
United States, Wisconsin
Local Institution
Glendale, Wisconsin, United States
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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ClinicalTrials.gov Identifier: NCT00162279    
Other Study ID Numbers: IM101-101
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents