Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

September 2, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the long term safety and tolerability of abatacept in subjects who have completed the initial 6 month open label treatment period [ Time Frame: open label treatment period ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Summarize the incidence of adverse events, serious adverse events and discontinuations due to adverse events at 6 months based on physical exam findings, vital signs, laboratory test results and adverse events reported during the course of the study.

Change History

Complete list of historical versions of study NCT00124982 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess efficacy and immunogenicity of abatacept in combination with non-biologic DMARDs [ Time Frame: open label treatment period ] [ Designated as safety issue: No ]
Assess maintenance of response in subjects who eliminate or reduce their dose of concomitant non-biologic background DMARD therapy [ Time Frame: open label period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

1) A disease activity score at 6 months and over time. 2) Percentage of subjects achieving remission at 6 months. 3) Discontinuation rate in subjects

Descriptive Information

Brief Title ^ICMJE

Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

Official Title ^ICMJE

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Brief Summary

The purpose of this study is to learn if Abatacept will provide clinical efficacy to subjects who have failed an anti-TNF therapy. The safety of this treatment will also be studied.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Abatacept

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

535

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completed double-blind portion of the IM101064 study.
Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
American College of Rheumatology (ACR) functional class I, II, III
Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria:

Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Czech Republic, France, Germany, Ireland, Italy, Mexico, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00124982

Responsible Party

Study ID Numbers ^ICMJE

IM101-064

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

September 2009

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