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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date December 6, 2010
Study Start Date  ICMJE October 2000
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2007)
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone [ Time Frame: at 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Abatacept combined with etanercept will have greater clinical efficacy compared to subjects receiving etanercept alone at 6 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2007)
ACR 50 and 70 will be evaluated [ Time Frame: at 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
ACR 20 and 50 will be evaluated at 6 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Abatacept in Combination With Etanercept
Official Title  ICMJE 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
Brief Summary The Study was designed to look at the safety and efficacy of abatacept in combination with etanercept.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Abatacept
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
141
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All subjects who had completed the short term portion of IM101-101.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162279
Other Study ID Numbers  ICMJE IM101-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP