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The Study of Abatacept in Combination With Etanercept

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162279
First received: September 9, 2005
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Abatacept
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

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

Estimated Enrollment: 141
Study Start Date: October 2000
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects who had completed the short term portion of IM101-101.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162279

  Show 35 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00162279     History of Changes
Other Study ID Numbers: IM101-101
Study First Received: September 9, 2005
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
TNFR-Fc fusion protein
Antirheumatic Agents
Therapeutic Uses
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013