The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)
Unnamed facility
Nunoya-cho Goshogawara, Aomori, Japan
Unnamed facility
Kokubu, Kurume, Fukuoka, Japan
Unnamed facility
Inomachi Takasaki, Gunma, Japan
Unnamed facility
Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.
DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).
Time frame: weeks 4 and 12
Area Under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12.
Time frame: 7 days after week 4 and 7 days after week 12
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Higashiuneno Kawanishi, Hyōgo, Japan
Unnamed facility
Mukogawa-cho, Nishinomiya, Hyōgo, Japan
Unnamed facility
Kamiyokoba, Tsukuba, Ibaraki, Japan
Unnamed facility
Douhaku, Suzuka, Mie-ken, Japan
Unnamed facility
Hazama, Isobe-cho, Shima, Mie-ken, Japan
Unnamed facility
Hisai Myojin-cho, Tsu, Mie-ken, Japan
Unnamed facility
Yamato, Sasebo, Nagasaki, Japan
...and 2 more locations