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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

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

Hide Study Locations

Locations

Japan
Local Institution
Chiba-Shi, Japan, 260-0801
Japan, Aichi
Local Institution
Nagoya, Aichi, Japan, 466-8550
Local Institution
Nagoya-Shi, Aichi, Japan, 460-0001
Japan, Aomori
Local Institution
Goshogawara-Shi, Aomori, Japan, 037-0053
Japan, Chiba
Local Institution
Chiba-Shi, Chiba, Japan, --
Japan, Fukui
Local Institution
Fukui-Shi, Fukui, Japan, 910-0041
Local Institution
Fukui-Shi, Fukui, Japan, 9100067
Japan, Fukuoka
Local Institution
Kitakyushu-Shi, Fukuoka, Japan, 807-8555
Local Institution
Fukuoka-Shi, Fukuoka, Japan, 810-0065
Local Institution
Fukuoka-Shi, Fukuoka, Japan, 810-0065
Local Institution
Fukuoka-Shi, Fukuoka, Japan, 812-0025
Japan, Hiroshima
Local Institution
Higashi-Hiroshima-Shi, Hiroshima, Japan, 739-0002
Japan, Hokkaido
Local Institution
Sapporo-City, Hokkaido, Japan, 060-8604
Local Institution
Sapporo-City, Hokkaido, Japan, 060-0001
Local Institution
Sapporo City, Hokkaido, Japan, 060-8648
Japan, Hyogo
Local Institution
Kato-Gun, Hyogo, Japan, 673-1462
Local Institution
Kanzaki-Gun, Hyogo, Japan, 679-2414
Japan, Ibaraki
Local Institution
Tsukuba-Shi, Ibaraki, Japan, 305-0005
Local Institution
Hitachi-Shi, Ibaraki, Japan, 316-0035
Japan, Kanagawa
Local Institution
Sagamihara-Shi, Kanagawa, Japan, 228-8522
Japan, Miyagi
Local Institution
Sendai-Shi, Miyagi, Japan, 982-0032
Local Institution
Sendai-Shi, Miyagi, Japan, 981-0911
Local Institution
Sendai, Miyagi, Japan, --
Japan, Nagano
Local Institution
Nagano-Shi, Nagano, Japan, 380-8582
Japan, Okayama
Local Institution
Tsukubo-Gun, Okayama, Japan, 701-0304
Japan, Osaka
Local Institution
Kawachinagano-Shi, Osaka, Japan, 86-0008
Japan, Saga
Local Institution
Ureshino-Shi, Saga, Japan, 843-0301
Japan, Saitama
Local Institution
Iruma-Gun, Saitama, Japan, 350-0495
Local Institution
Kawagoe-Shi, Saitama, Japan, 350-8550
Local Institution
Kitamoto-Shi, Saitama, Japan, 364-0026
Japan, Shizuoka
Local Institution
Hamamatsu-Shi, Shizuoka, Japan, 430-0906
Japan, Tochigi
Local Institution
Kawachigun, Tochigi, Japan, 329-1104
Local Institution
Shimotsuke-Shi, Tochigi, Japan, 3290498
Japan, Tokyo
Local Institution
Arakawa-Ku, Tokyo, Japan, 116-0011
Local Institution
Shinjuku-Ku, Tokyo, Japan, 162-0054
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-0022
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-8519
Local Institution
Setagaya-Ku, Tokyo, Japan, 155-0032
Japan, Toyama
Local Institution
Takaoka-Shi, Toyama, Japan, 933-8525

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-129
Study First Received:	June 7, 2007
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00484289 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Rheumatic Diseases
Immunosuppressive Agents

Pharmacologic Actions
Abatacept
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009