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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
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.
Time frame: at 6 months
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
Time frame: at 6 months
Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required)
Time frame: at 6 months
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Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Goshogawara-Shi, Aomori, Japan
Local Institution
Chiba, Chiba, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kitakyushu-Shi, Fukuoka, Japan
Local Institution
Higashi-Hiroshima-Shi, Hiroshima, Japan
...and 28 more locations