A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis - Tabular View

Tracking Information
First Received Date ^ICMJE	November 11, 2002
Last Updated Date	October 6, 2009
Start Date ^ICMJE	December 2002
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 6, 2009)	incidence of AE, SAE, discontinuation due to AE [ Time Frame: Throughout the study, for 60 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 30, 2008)	incidence of AE, SAE, discontinuation due to AE
Change History	Complete list of historical versions of study NCT00048932 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Official Title ^ICMJE
Brief Summary	The purpose of this clinical research study is to learn if BMS-188667 is safe when co-administered with other approved rheumatoid arthritis medications.
Detailed Description	Open Label - Active study drug (solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly)
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: Abatacept Drug: Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1795
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV Subjects must be taking 1 or more DMARDs and/or biologic approved for RA for at least 3 months and be on a stable dose for 28 days prior to Day 1. Exclusion: Other auto-immune disease as a main diagnosis (e.g. SLE, Scleroderma) Active TB requiring Rx within last 3 years
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00048932
Responsible Party	Study Director, Bristol-Myers Squibb
Study ID Numbers ^ICMJE	IM101-031
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP