カイダ ケンイチ
KAIDA Kenichi
海田 賢一 所属 埼玉医科大学 医学部 総合医療センター 脳神経内科 職種 教授 |
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論文種別 | 学術雑誌(原著) |
言語種別 | 英語 |
査読の有無 | 査読あり |
表題 | Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial |
掲載誌名 | 正式名:JMIR Research Protocols |
出版社 | JMIR Publications Inc. |
巻・号・頁 | 9(4),e17117-e17117頁 |
著者・共著者 | Shinobu Shimizu,Masahiro Iijima,Yuki Fukami,Natsuko Tamura,Masahiro Nakatochi,Masahiko Ando,Ryoji Nishi,Haruki Koike,Kenichi Kaida,Michiaki Koga,Takashi Kanda,Hidenori Ogata,Jun-Ichi Kira,Masahiro Mori,Satoshi Kuwabara,Masahisa Katsuno |
発行年月 | 2020/04 |
概要 | <sec><title>Background</title>Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated peripheral neuropathy that is currently classified into several clinical subtypes, which are presumed to have different pathogenic mechanisms. Recently, studies identified a subgroup of patients with CIDP who were positive for IgG4 autoantibodies against paranodal proteins, such as neurofascin-155 and contactin-1, who respond poorly to first-line therapies for typical CIDP, including intravenous immunoglobulin therapy.</sec><sec><title>Objective</title>This study aims to evaluate the efficacy and safety of intravenous rituximab according to IgG4 autoantibody status in patients with refractory CIDP.</sec><sec><title>Methods</title>The Evaluation of the Efficacy and Safety of Rituximab in Refractory CIDP Patients with IgG4 Autoantibodies in the Exploratory Clinical (RECIPE) trial consists of 2 cohorts: a multicenter, placebo-controlled, randomized study cohort of 15 patients with IgG4 autoantibody-positive CIDP (rituximab:placebo = 2:1) and an open-label trial cohort of 10 patients with antibody-negative CIDP. The primary endpoint is improvement |
DOI | 10.2196/17117 |
PMID | 32234705 |