Clinical trial NCT00345748: A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 194
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: at 6 months
Secondary outcomes:
measure: 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
timeFrame: at 6 months
measure: Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)
timeFrame: at 6 months
Other outcomes:
Locations:
city: Nagoya-Shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Goshogawara-Shi
country: Japan
facility: Local Institution
state: Aomori
city: Chiba-Shi
country: Japan
facility: Local Institution
state: Chiba
city: Fukui-Shi
country: Japan
facility: Local Institution
state: Fukui
city: Fukui-Shi
country: Japan
facility: Local Institution
state: Fukui
city: Fukuoka-Shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Fukuoka-Shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kitakyushu-Shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Higashi-Hiroshima-Shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo City
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-City
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-City
country: Japan
facility: Local Institution
state: Hokkaido
city: Kanzaki-Gun
country: Japan
facility: Local Institution
state: Hyogo
city: Kato-Gun
country: Japan
facility: Local Institution
state: Hyogo
city: Hitachi-Shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Tsukuba-Shi
country: Japan
facility: Local Institution
state: Ibaraki
city: Sagamihara-Shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Sendai-Shi
country: Japan
facility: Local Institution
state: Miyagi
city: Sendai-Shi
country: Japan
facility: Local Institution
state: Miyagi
city: Sendai
country: Japan
facility: Local Institution
state: Miyagi
city: Nagano-Shi
country: Japan
facility: Local Institution
state: Nagano
city: Tsukubo-Gun
country: Japan
facility: Local Institution
state: Okayama
city: Kawachinagano-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Ureshino-Shi
country: Japan
facility: Local Institution
state: Saga
city: Iruma-Gun
country: Japan
facility: Local Institution
state: Saitama
city: Kawagoe-Shi
country: Japan
facility: Local Institution
state: Saitama
city: Kitamoto-Shi
country: Japan
facility: Local Institution
state: Saitama
city: Hamamatsu-Shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Kawachigun
country: Japan
facility: Local Institution
state: Tochigi
city: Arakawa-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Bunkyo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Bunkyo-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Takaoka-Shi
country: Japan
facility: Local Institution
state: Toyama
city: Chiba-Shi
country: Japan
facility: Local Institution
city: Tochigi
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: