Effects of vedolizumab in Japanese patients with Crohn's disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses.

"Conflict of interest Kenji Watanabe has received honoraria and research funding from AbbVie GK (AbbVie), Mitsubishi Tanabe Pharma (Mitsubishi Tanabe), EA Pharma (EA), Takeda Pharmaceutical (Takeda), Kyorin Pharmaceutical (Kyorin), Mochida Pharmaceutical (Mochida) and Janssen Pharmaceutical (Janssen); research funding from Astellas Pharma (Astellas), JIMRO, Zeria Pharmaceutical (Zeria), Otsuka Pharmaceutical (Otsuka) and Asahi Kasei Medical (Asahi Kasei). Satoshi Motoya has received honoraria and research funding from Janssen and Takeda; honoraria from Mitsubishi Tanabe, and Mochida; research funding from Pfizer Japan (Pfizer). Haruhiko Ogata has received honoraria from Takeda; research funding from Mitsubishi Tanabe, Mochida, Pfizer and AbbVie. Takanori Kanai has received honoraria and research funding from Mitsubishi Tanabe, Miyarisan Pharmaceutical (Miyarisan) and Takeda; honoraria from Astellas and AstraZeneca; research funding from EN Otsuka, Ezaki Glico, Otsuka, AbbVie, Mochida, Kyorin, Daiichi Sankyo, Nippon Kayaku, Yakult, Zeria, Sumitomo Dainippon Pharma, Ono Pharmaceutical, EA, Eisai, JIMRO, Chugai Pharmaceutical (Chugai) and UCB Japan (UCB). Toshiyuki Matsui has received honoraria and research funding from EA, Ajinomoto Seiyaku (Ajinomoto), AbbVie, Eisai, Kyorin, Zeria, Takeda, Mitsubishi Tanabe and Mochida; research funding from Miyarisan, Otsuka, Asahi Kasei, Astellas, AstraZeneca, MSD, JIMRO, Taiho Pharmaceutical (Taiho), Daiichi Sankyo, Nippon Kayaku, Kyowa Hakko Kirin, UCB and Chugai. Yasuo Suzuki has received honoraria and research funding from Mitsubishi Tanabe, AbbVie, EA and Mochida; honoraria from Janssen, Zeria and Kyorin; research funding from JIMRO, Kissei and Nippon Kayaku. Mitsuhiro Shikamura, Kenkichi Sugiura, Kazunori Oda, Tetsuharu Hori, and Takahiro Araki are employees of Takeda. Mamoru Watanabe has received honoraria and research funding from Mitsubishi Tanabe, Takeda, EA, Zeria and Gilead Sciences; honoraria from Ajinomoto, Janssen, Celltrion Healthcare and Pfizer; research funding from Nippon Kayaku, Mochida, Kissei, Miyarisan, Asahi Kasei, JIMRO, Kyorin, AbbVie, Kyowa Hakko Kirin, Kaken Pharmaceutical, Alfresa Pharma, Ayumi Pharmaceutical, Astellas, MSD, Daiichi Sankyo, Taiho, Toray Industries, Chugai and Fujirebio. Toshifumi Hibi has received honoraria and research funding from EA and Zeria; honoraria from Takeda, Mitsubishi Tanabe, AbbVie, Zeria, JIMRO, Janssen and Pfizer; research funding from Nippon Kayaku and Mochida."

"Funding The study was funded by Takeda Pharmaceutical Company Limited."

"This Phase 3 randomized, double-blind, placebo-controlled, parallel group study (ClinicalTrials.gov number, NCT02038920) assessed vedolizumab as induction and maintenance therapy in Japanese patients with CD at 77 centers in Japan, in accordance with the Declaration of Helsinki, International Conference on Harmonization guidelines, and relevant laws and regulations. The protocol was approved by appropriate institutional review boards. Written informed consent was obtained from all patients."