Efficacy, Pharmacokinetics, Safety and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japan

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept (Drug); Abatacept (Drug); Abatacept (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, 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 assess the efficacy of abatacept after subcutaneous administration and intravenous administration in Japanese active rheumatoid arthritis (RA) subjects with inadequate response to methotrexate (MTX), and on background MTX in the short term.

Official title: A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: American College of Rheumatology (ACR) 20 response rates at 6 months of treatment of abatacept after subcutaneous administration and intravenous administration

Secondary outcome:

Efficacy: ACR 50 and ACR 70 response rates, Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS28) after 6 months of treatments

Pharmacokinetics: the trough level serum concentration of abatacept after subcutaneous administration and intravenous administration at the steady state

Anti-abatacept antibody and anti-cytotoxic T-lymphocyte antigen 4 (anti CTLA-4) antibody (immunogenicity) of abatacept after subcutaneous administration and intravenous administration in the short-term

Safety: the clinical adverse events (AEs) and adverse drug reactions (ADRs), vital signs and laboratory abnormalities of abatacept after subcutaneous administration and intravenous administration in the short-term

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who are considered methotrexate inadequate responders

- 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint

count)

Exclusion Criteria:

- Subjects who meet diagnostic criteria for any other rheumatic disease (eg, lupus

erythematous)

- Subjects with active vasculitis of a major organ system (except for subcutaneous

rheumatoid nodules)

- Subjects with severe chronic or recurrent bacterial infections

- Subjects who had exposure to an anti-TNF therapy, tocilizumab and/or rituximab

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, Narita-Shi, Chiba 2868523, Japan; Recruiting
Site 025

Local Institution, Fukuoka-Shi, Fukuoka 8108563, Japan; Recruiting
Site 018

Local Institution, Fukuoka-Shi, Fukuoka 8108563, Japan; Recruiting
Site 019

Local Institution, Kitakyushu-Shi, Fukuoka 8078555, Japan; Recruiting
Site 021

Local Institution, Kurume-Shi, Fukuoka 8308543, Japan; Recruiting
Site 031

Local Institution, Maebashi-Shi, Gunma 3718511, Japan; Recruiting
Site 006

Local Institution, Takasaki-Shi, Gunma 3700053, Japan; Recruiting
Site 023

Local Institution, Higashi-Hiroshima-Shi, Hiroshima 7390002, Japan; Recruiting
Site 017

Local Institution, Sapporo, Hokkaido 0630005, Japan; Recruiting
Site 022

Local Institution, Sapporo-Shi, Hokkaido 0608648, Japan; Recruiting
Site 001

Local Institution, Sapporo-Shi, Hokkaido 0608604, Japan; Recruiting
Site 002

Local Institution, Sapporo-Shi, Hokkaido 0630811, Japan; Recruiting
Site 032

Local Institution, Kanzaki-Gun, Hyogo 6792414, Japan; Recruiting
Site 015

Local Institution, Kato-Shi, Hyogo 6731462, Japan; Recruiting
Site 016

Local Institution, Kobe-Shi, Hyogo 6500001, Japan; Recruiting
Site 029

Local Institution, Hitachi-Shi, Ibaraki 3160035, Japan; Recruiting
Site 003

Local Institution, Kagoshima-Shi, Kagoshima 8900067, Japan; Recruiting
Site 034

Local Institution, Sagamihara-Shi, Kanagawa 2520392, Japan; Recruiting
Site 012

Local Institution, Yokohama-Shi, Kanagawa 2220036, Japan; Recruiting
Site 011

Local Institution, Yokohama-Shi, Kanagawa 2360037, Japan; Recruiting
Site 027

Local Institution, Nagano-Shi, Nagano 3808582, Japan; Recruiting
Site 013

Local Institution, Kurashiki-Shi, Okayama 7128044, Japan; Recruiting
Site 030

Local Institution, Hannan-Shi, Osaka 5990212, Japan; Recruiting
Site 028

Local Institution, Iruma-Gun, Saitama 3500495, Japan; Recruiting
Site 007

Local Institution, Kawagoe-Shi, Saitama 3508550, Japan; Recruiting
Site 008

Local Institution, Kitamoto-Shi, Saitama 3640026, Japan; Recruiting
Site 024

Local Institution, Tokorozawa-Shi, Saitama 3591111, Japan; Recruiting
Site 035

Local Institution, Hamamatsu-Shi, Shizuoka 4308558, Japan; Recruiting
Site 014

Local Institution, Shizuoka-Shi, Shizuoka 4208623, Japan; Recruiting
Site 033

Local Institution, Shimotsuke-Shi, Tochigi 3290498, Japan; Recruiting
Site 005

Local Institution, Utsunomiya-Shi, Tochigi 3291193, Japan; Recruiting
Site 004

Local Institution, Bunkyo-Ku, Tokyo 1138519, Japan; Recruiting
Site 010

Local Institution, Nakano-Ku, Tokyo 1648541, Japan; Recruiting
Site 026

Local Institution, Shinjuku-Ku, Tokyo 1608582, Japan; Recruiting
Site 009

BMS Clinical Trials Disclosure

Investigator Inquiry form

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

Starting date: December 2009
Last updated: September 13, 2010