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A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
This study has been completed.

First Received on June 7, 2007.   Last Updated on February 10, 2011   History of Changes
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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 217
Study Start Date: December 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Abatacept
Vials (250 mg/vial), IV, 10 mg/kg, monthly infusion, until approved in Japan
Other Names:
  • Orencia®
  • BMS-188667

  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

Locations
Japan
Local Institution
Nagoya, Aichi, Japan, 466-8550
Local Institution
Nagoya-Shi, Aichi, Japan, 460-0001
Local Institution
Goshogawara-Shi, Aomori, Japan, 037-0053
Local Institution
Chiba-Shi, Chiba, Japan
Local Institution
Fukui-Shi, Fukui, Japan, 910-0041
Local Institution
Fukui-Shi, Fukui, Japan, 9103133
Local Institution
Fukui-Shi, Fukui, Japan, 9100067
Local Institution
Fukuoka-Shi, Fukuoka, Japan, 810-0065
Local Institution
Fukuoka-Shi, Fukuoka, Japan, 812-0025
Local Institution
Kitakyushu-Shi, Fukuoka, Japan, 807-8555
Local Institution
Higashi-Hiroshima-Shi, Hiroshima, Japan, 739-0002
Local Institution
Sapporo City, Hokkaido, Japan, 060-8648
Local Institution
Sapporo-City, Hokkaido, Japan, 060-8604
Local Institution
Sapporo-City, Hokkaido, Japan, 060-0001
Local Institution
Kanzaki-Gun, Hyogo, Japan, 679-2414
Local Institution
Kato-Gun, Hyogo, Japan, 673-1462
Local Institution
Hitachi-Shi, Ibaraki, Japan, 316-0035
Local Institution
Tsukuba-Shi, Ibaraki, Japan, 305-0005
Local Institution
Sagamihara-Shi, Kanagawa, Japan, 228-8522
Local Institution
Sendai, Miyagi, Japan
Local Institution
Sendai-Shi, Miyagi, Japan, 982-0032
Local Institution
Sendai-Shi, Miyagi, Japan, 981-0911
Local Institution
Nagano-Shi, Nagano, Japan, 380-8582
Local Institution
Tsukubo-Gun, Okayama, Japan, 701-0304
Local Institution
Kawachinagano-Shi, Osaka, Japan, 86-0008
Local Institution
Ureshino-Shi, Saga, Japan, 843-0301
Local Institution
Iruma-Gun, Saitama, Japan, 350-0495
Local Institution
Kawagoe-Shi, Saitama, Japan, 350-8550
Local Institution
Kitamoto-Shi, Saitama, Japan, 364-0026
Local Institution
Hamamatsu-Shi, Shizuoka, Japan, 430-0906
Local Institution
Kawachigun, Tochigi, Japan, 329-1104
Local Institution
Shimotsuke-Shi, Tochigi, Japan, 3290498
Local Institution
Arakawa-Ku, Tokyo, Japan, 116-0011
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-0022
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-8519
Local Institution
Setagaya-Ku, Tokyo, Japan, 155-0032
Local Institution
Shinjuku-Ku, Tokyo, Japan, 162-0054
Local Institution
Takaoka-Shi, Toyama, Japan, 933-8525
Local Institution
Chiba-Shi, Japan, 260-0801
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00484289     History of Changes
Other Study ID Numbers: IM101-129
Study First Received: June 7, 2007
Last Updated: February 10, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012



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