Sato, Tomoo
Nagai, Masahiro
Watanabe, Osamu
Misu, Tatsuro
Takenouchi, Norihiro
Ohkubo, Ryuichi
Ishihara, Satoshi
Tsuboi, Yoshio
Katsuno, Masahisa
Nakagawa, Masanori
Matsushita, Takuya
Aso, Yasuhiro
Matsuura, Eiji
Tokashiki, Takashi
Mukaino, Akihiro
Adachi, Hiroaki
Nakanishi, Kaoru
Yamaguchi, Yusuke
Yamaguchi, Saaya
Yamano, Yoshihisa http://orcid.org/0000-0001-7527-0345
Clinical trials referenced in this document:
Documents that mention this clinical trial
Multicenter, randomized, double-blind, placebo-controlled phase 3 study of mogamulizumab with open-label extension study in a minimum number of patients with human T-cell leukemia virus type-1-associated myelopathy
https://doi.org/10.1007/s00415-024-12239-x
Funding for this research was provided by:
Kyowa Kirin
Article History
Received: 7 November 2023
Revised: 2 February 2024
Accepted: 3 February 2024
First Online: 2 March 2024
Declarations
:
: This study was sponsored by Kyowa Kirin Co., Ltd. We thank the patients who participated in this study as well as the investigators and site staff members who provided support. We thank ASCA Corporation for providing medical writing support, which was funded by Kyowa Kirin Co., Ltd., in accordance with Good Publication Practice guidelines (). T. Sato and Y. Yamano received grants and consulting fees/honoraria from Kyowa Kirin Co., Ltd. for this study. M. Nagai, O. Watanabe, T. Misu, N. Takenouchi, R. Ohkubo, S. Ishihara, Y. Tsuboi, M. Katsuno, M. Nakagawa, Y. Aso, E. Matsuura, T. Tokashiki, A. Mukaino, and H. Adachi received grants from Kyowa Kirin Co., Ltd. for this study. T. Matsushita received grant from Kyowa Kirin Co., Ltd. for this study and lecture fees/speaker’s bureaus from Takeda Pharmaceutical Company Ltd., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, and Alexion Pharmaceuticals, Inc. outside the study. K. Nakanishi, Y. Yamaguchi, and S. Yamaguchi are employees of Kyowa Kirin Co., Ltd.
: This study was performed in accordance with the ethical standards of the Declaration of Helsinki and in compliance with the Ministerial Ordinance on Good Clinical Practice for Drugs (Ordinance of the Ministry of Health and Welfare No. 28, 1997), the Pharmaceutical Affairs Law, the Ministerial Ordinance on the Partial Revision of the Ordinance, and other related notifications. This study was approved by the internal review board at each study site, and the study was registered at Japanese Pharmaceutical Information as JapicCTI-173608.
: Written informed consent was obtained from all participating patients prior to the study initiation.
: The authors affirm that human research participants provided informed consent for publication of data from the clinical trial.