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A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS)

A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS)

We, therefore, designed the Japanese Eculizumab Trial for Guillain-Barré syndrome (JET-GBS) study to investigate the efficacy and safety of eculizumab in GBS patients. This is a prospective, multicenter, placebo-controlled, double-blind, randomized phase II trial in patients with GBS. A schematic depiction of the trial design is presented in Figure 1. The trial is composed of 3 periods: the screening period, investigation product (IP) administration period, and post-IP period.

Nobuko Yamaguchi, Sonoko Misawa, Yasunori Sato, Kengo Nagashima, Kanako Katayama, Yukari Sekiguchi, Yuta Iwai, Hiroshi Amino, Tomoki Suichi, Takanori Yokota, Yoichiro Nishida, Nobuo Kohara, Koichi Hirata, Kazutoshi Nishiyama, Ichiro Yabe, Ken-Ichi Kaida, Norihiro Suzuki, Hiroyuki Nodera, Shoji Tsuji, Haruki Koike, Jun-Ichi Kira, Hideki Hanaoka, Susumu Kusunoki, Satoshi Kuwabara, JET-GBS Group

JMIR Res Protoc 2016;5(4):e210