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. Identifier: NCT00162279
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : December 6, 2010
Information provided by:
Bristol-Myers Squibb

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 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

U.S. FDA Resources

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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

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

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 identifier (NCT number): NCT00162279

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Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information: Identifier: NCT00162279     History of Changes
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:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors