A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345748
• Other study ID #: IM101-071
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2006
• Last updated: April 11, 2011
• Start date: June 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization

Exclusion Criteria:

• no current infection or other evolutive or uncontrolled disease

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept
Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks
• Placebo
Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks

Locations

Country	Name	City	State
Japan	Local Institution	Arakawa-Ku	Tokyo
Japan	Local Institution	Bunkyo-Ku	Tokyo
Japan	Local Institution	Bunkyo-Ku	Tokyo
Japan	Local Institution	Chiba-Shi
Japan	Local Institution	Chiba-Shi	Chiba
Japan	Local Institution	Fukui-Shi	Fukui
Japan	Local Institution	Fukui-Shi	Fukui
Japan	Local Institution	Fukuoka-Shi	Fukuoka
Japan	Local Institution	Fukuoka-Shi	Fukuoka
Japan	Local Institution	Goshogawara-Shi	Aomori
Japan	Local Institution	Hamamatsu-Shi	Shizuoka
Japan	Local Institution	Higashi-Hiroshima-Shi	Hiroshima
Japan	Local Institution	Hitachi-Shi	Ibaraki
Japan	Local Institution	Iruma-Gun	Saitama
Japan	Local Institution	Kanzaki-Gun	Hyogo
Japan	Local Institution	Kato-Gun	Hyogo
Japan	Local Institution	Kawachigun	Tochigi
Japan	Local Institution	Kawachinagano-Shi	Osaka
Japan	Local Institution	Kawagoe-Shi	Saitama
Japan	Local Institution	Kitakyushu-Shi	Fukuoka
Japan	Local Institution	Kitamoto-Shi	Saitama
Japan	Local Institution	Nagano-Shi	Nagano
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Nagoya-Shi	Aichi
Japan	Local Institution	Sagamihara-Shi	Kanagawa
Japan	Local Institution	Sapporo City	Hokkaido
Japan	Local Institution	Sapporo-City	Hokkaido
Japan	Local Institution	Sapporo-City	Hokkaido
Japan	Local Institution	Sendai	Miyagi
Japan	Local Institution	Sendai-Shi	Miyagi
Japan	Local Institution	Sendai-Shi	Miyagi
Japan	Local Institution	Setagaya-Ku	Tokyo
Japan	Local Institution	Shinjuku-Ku	Tokyo
Japan	Local Institution	Takaoka-Shi	Toyama
Japan	Local Institution	Tochigi
Japan	Local Institution	Tsukuba-Shi	Ibaraki
Japan	Local Institution	Tsukubo-Gun	Okayama
Japan	Local Institution	Ureshino-Shi	Saga

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline.		at 6 months	No
Secondary	ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity		at 6 months	No
Secondary	Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)		at 6 months	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm