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

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Taku Seriu, MD, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Bio-availability Study

Primary outcome: 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.

Secondary outcome: ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, safety, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity

Minimum age: 20 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- no current infection or other evolutive or uncontrolled disease

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Nagoya, Aichi 466-8550, Japan; Recruiting
Site 030

Local Institution, Nagoya-Shi, Aichi 460-0001, Japan; Recruiting
Site 031

Local Institution, Chiba-Shi, Chiba --, Japan; Recruiting
Site 013

Local Institution, Fukui-Shi, Fukui 910-0067, Japan; Recruiting
Site 026

Local Institution, Fukui-Shi, Fukui 910-0041, Japan; Recruiting
Site 027

Local Institution, Kitakyushu-Shi, Fukuoka 807-8555, Japan; Recruiting
Site 038

Local Institution, Fukuoka-Shi, Fukuoka 810-0065, Japan; Recruiting
Site 039

Local Institution, Fukuoka-Shi, Fukuoka 810-0065, Japan; Recruiting
Site 040

Local Institution, Fukuoka-Shi, Fukuoka 812-0025, Japan; Recruiting
Site 041

Local Institution, Chiba-Shi 260-0801, Japan; Recruiting
Site 014

Local Institution, Tochigi 329-0498, Japan; Recruiting
Site 007

Local Institution, Higashi-Hiroshima-Shi, Hiroshima 739-0002, Japan; Recruiting
Site 037

Local Institution, Sapporo-City, Hokkaido 060-8604, Japan; Recruiting
Site 001

Local Institution, Sapporo-City, Hokkaido 060-0001, Japan; Recruiting
Site 002

Local Institution, Sapporo City, Hokkaido 060-8648, Japan; Recruiting
Site 043

Local Institution, Kato-Gun, Hyogo 673-1462, Japan; Recruiting
Site 033

Local Institution, Kanzaki-Gun, Hyogo 679-2414, Japan; Recruiting
Site 034

Local Institution, Nishinomiya-Shi, Hyogo 663-8131, Japan; Not yet recruiting
Site 035

Local Institution, Tsukuba-Shi, Ibaraki 305-0005, Japan; Recruiting
Site 008

Local Institution, Hitachi-Shi, Ibaraki 316-0035, Japan; Recruiting
Site 009

Local Institution, Sagamihara-Shi, Kanagawa 228-8522, Japan; Recruiting
Site 021

Local Institution, Sendai-Shi, Miyagi 982-0032, Japan; Recruiting
Site 004

Local Institution, Sendai-Shi, Miyagi 981-0911, Japan; Recruiting
Site 005

Local Institution, Sendai, Miyagi --, Japan; Not yet recruiting
Site 044

Local Institution, Nagano-Shi, Nagano 380-8582, Japan; Recruiting
Site 028

Local Institution, Tsukubo-Gun, Okayama 701-0304, Japan; Recruiting
Site 036

Local Institution, Kawachinagano-Shi, Osaka 86-0008, Japan; Recruiting
Site 032

Local Institution, Ureshino-Shi, Saga 843-0301, Japan; Recruiting
Site 042

Local Institution, Iruma-Gun, Saitama 350-0495, Japan; Recruiting
Site 010

Local Institution, Kawagoe-Shi, Saitama 350-8550, Japan; Recruiting
Site 011

Local Institution, Kitamoto-Shi, Saitama 364-0026, Japan; Recruiting
Site 012

Local Institution, Hamamatsu-Shi, Shizuoka 430-0906, Japan; Recruiting
Site 029

Local Institution, Kawachigun, Tochigi 329-1104, Japan; Recruiting
Site 006

Local Institution, Arakawa-Ku, Tokyo 116-0011, Japan; Recruiting
Site 015

Local Institution, Shinjuku-Ku, Tokyo 162-0054, Japan; Recruiting
Site 016

Local Institution, Bunkyo-Ku, Tokyo 113-0022, Japan; Recruiting
Site 018

Local Institution, Bunkyo-Ku, Tokyo 113-8519, Japan; Recruiting
Site 019

Local Institution, Setagaya-Ku, Tokyo 155-0032, Japan; Recruiting
Site 020

Local Institution, Takaoka-Shi, Toyama 933-8525, Japan; Recruiting
Site 025

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: October 2006
Last updated: October 9, 2007