A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Takashi Kaneko, MD, Study Director, Affiliation: Bristol Myers KK

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 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.

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

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: 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

Secondary outcome:

ACR 20, ACR 50 and ACR 70 response rates over time

DAS-28 and HAQ

Quality of life by using SF36 questionnaire

Immunogenicity

Biomarkers

Population Pharmacokinetics

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

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

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; Not yet recruiting
Site 026

Local Institution, Nagoya-Shi, Aichi 460-0001, Japan; Recruiting
Site 027

Local Institution, Goshogawara-Shi, Aomori 037-0053, Japan; Recruiting
Site 003

Local Institution, Chiba-Shi, Chiba --, Japan; Not yet recruiting
Site 013

Local Institution, Fukui-Shi, Fukui 910-0067, Japan; Recruiting
Site 022

Local Institution, Fukui-Shi, Fukui 910-0041, Japan; Recruiting
Site 023

Local Institution, Kitakyushu-Shi, Fukuoka 807-8555, Japan; Recruiting
Site 034

Local Institution, Fukuoka-Shi, Fukuoka 810-0065, Japan; Recruiting
Site 035

Local Institution, Fukuoka-Shi, Fukuoka 810-0065, Japan; Recruiting
Site 036

Local Institution, Fukuoka-Shi, Fukuoka 812-0025, Japan; Recruiting
Site 037

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 033

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

Local Institution, Sapporo-City, Hokkaido 060-0001, Japan; Not yet recruiting
Site 002

Local Institution, Sapporo City, Hokkaido 060-8648, Japan; Recruiting
Site 039

Local Institution, Kato-Gun, Hyogo 673-1462, Japan; Recruiting
Site 029

Local Institution, Kanzaki-Gun, Hyogo 679-2414, Japan; Recruiting
Site 030

Local Institution, Nishinomiya-Shi, Hyogo 663-8131, Japan; Not yet recruiting
Site 031

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 020

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

Local Institution, Sendai-Shi, Miyagi 981-0911, Japan; Not yet recruiting
Site 005

Local Institution, Sendai, Miyagi --, Japan; Not yet recruiting
Site 040

Local Institution, Nagano-Shi, Nagano 380-8582, Japan; Recruiting
Site 024

Local Institution, Tsukubo-Gun, Okayama 701-0304, Japan; Recruiting
Site 032

Local Institution, Kawachinagano-Shi, Osaka 86-0008, Japan; Recruiting
Site 028

Local Institution, Ureshino-Shi, Saga 843-0301, Japan; Recruiting
Site 038

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; Not yet recruiting
Site 012

Local Institution, Hamamatsu-Shi, Shizuoka 430-0906, Japan; Recruiting
Site 025

Local Institution, Kawachigun, Tochigi 329-1104, Japan; Not yet recruiting
Site 006

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

Local Institution, Shinjuku-Ku, Tokyo 162-0054, Japan; Not yet recruiting
Site 016

Local Institution, Bunkyo-Ku, Tokyo 113-0022, Japan; Not yet recruiting
Site 017

Local Institution, Bunkyo-Ku, Tokyo 113-8519, Japan; Not yet recruiting
Site 018

Local Institution, Setagaya-Ku, Tokyo 155-0032, Japan; Recruiting
Site 019

Local Institution, Takaoka-Shi, Toyama 933-8525, Japan; Recruiting
Site 021

BMS Clinical Trials Disclosure

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

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