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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00484289

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	180
Study Start Date:	December 2006
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Abatacept Vials (250 mg/vial), IV, 10 mg/kg, monthly infusion, until approved in Japan

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484289

Show 39 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-129
Study First Received:	June 7, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00484289
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Abatacept
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009