20
Participants
Start Date
July 12, 2022
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
Satralizumab (Genetical Recombination)
"Efficacy Evaluation Period:~The study drug will be administered at a dose of 120 mg subcutaneously at initial, 2-week, 4-week, and 4-week intervals thereafter. Efficacy will be assessed after 24 weeks of study drug administration. Subjects who demonstrate efficacy and wish to continue treatment will receive the study drug for 24 weeks and moving to the continuous treatment period. In all other cases, the study will be terminated after 24 weeks of the efficacy evaluation period without the administration of study drug.~Continuation Dosing Period\[1\]:~Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued 28 weeks (52 weeks total) treatment with satralizumab.~Continuation Dosing Period\[2\]:~Subjects completed continuation dosing period\[1\], clinically capable of continued administration, and wish to continue will receive continued treatment with satralizumab until the end of this study period."
Kagoshima University Hospital, Kagoshima
Chiba University Hospital, Chiba
Kyushu University Hospital, Fukuoka
Kobe University Hospital, Kobe
Kurume University Hospital, Kurume
Kyorin University Hospital, Mitaka
Nagoya University Hospital, Nagoya
Hokkaido University Hospital, Sapporo
International University of Health and Welfare Mita Hospital, Tokyo
Japan Agency for Medical Research and Development
OTHER_GOV
Keio University
OTHER
Chugai Pharmaceutical
INDUSTRY
International University of Health and Welfare
OTHER