88
Participants
Start Date
June 24, 2023
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
Rituximab (genetical recombination)
Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.
Placebo
Administer placebo IV infusion every two weeks for two doses in double-blind phase.
Rituximab (genetical recombination)
Patients who remain to be ICR II (Incomplete Remission Type II) or NR (No Response) until Week 26 in the double-blind phase, if the patients wish to move to the open-label phase and the investigator or a subinvestigator considers the move necessary, the patient will move to the open-label phase and receive 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses after the readministration criteria are confirmed to be met.
RECRUITING
Juntendo University Urayasu Hospital, Urayasu
RECRUITING
Hamamatsu University Hosptial, Hamamatsu
RECRUITING
Anjo Kosei Hospital, Anjo
RECRUITING
Nagoya University Hospital, Nagoya
RECRUITING
Fujita Health University hospital, Toyoake
RECRUITING
Konan Kosei Hospital, Kōnan
RECRUITING
Mie University Hospial, Tsu
RECRUITING
Tazuke Kofukai, Medical Research Institute, Kitano Hospital, Osaka
RECRUITING
Osaka University Hospital, Osaka
RECRUITING
University Hospital,Kyoto Prefectural University of Medicine, Kyoto
RECRUITING
Kyoto University Hospital, Kyoto
RECRUITING
Kyushu University Hospital, Fukuoka
RECRUITING
Kurume University Hospial, Kurume
RECRUITING
Kumamoto University Hospital, Kumamoto
RECRUITING
Kanazawa University Hospital, Kanazawa
RECRUITING
Tohoku University Hospital, Sendai
RECRUITING
Kasugai Municipal Hospital, Kasugai
RECRUITING
Asahikawa Medical University Hospital, Asahikawa
Shoichi Maruyama MD PhD
OTHER