A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

June 7, 2007

Last Updated Date

November 4, 2009

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary is safety for chronic use of abatacept. Adverse events will be assessed by: Date of onset of adverse events, seriousness, & causal relationship to study drug, outcome, action taken for investigational product administration, & treatment required [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00484289 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

ACR 20, ACR 50 and ACR 70 response rates over time [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
DAS-28 and HAQ [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Quality of life by using SF36 questionnaire [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Biomarkers [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Population Pharmacokinetics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

ACR 20, ACR 50 and ACR 70 response rates over time [ Time Frame: throughout the study ]
DAS-28 and HAQ [ Time Frame: throughout the study ]
Quality of life by using SF36 questionnaire [ Time Frame: throughout the study ]
Immunogenicity [ Time Frame: throughout the study ]
Biomarkers [ Time Frame: throughout the study ]
Population Pharmacokinetics [ Time Frame: throughout the study ]

Descriptive Information

Brief Title ^ICMJE

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

Official Title ^ICMJE

A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101071, IM101034, and Also Special DMARD Failures

Brief Summary

The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis having completed clinical studies IM101071, IM101034, and also DMARDs failures with MTX intolerance.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-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

Active, not recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

February 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The subjects having completed study IM101071 and IM101034, and patients not previously exposed to Abatacept failing other DMARDs and having MTX intolerance.
No current infection or other evolutive or uncontrolled disease

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00484289

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

IM101-129

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

January 2009

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