WEKO3
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An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance
http://hdl.handle.net/10069/39631
http://hdl.handle.net/10069/39631ce27a864-781c-478d-a19a-2ca439e63733
名前 / ファイル | ライセンス | アクション |
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Medicine99_18328.pdf (309.6 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2020-01-23 | |||||
タイトル | ||||||
タイトル | An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | colchicine-resistant | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | FMF | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | IL-6 | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | open-label | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | tocilizumab | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Koga, Tomohiro
× Koga, Tomohiro× Hagimori, Naoko× Sato, Shuntaro× Morimoto, Shinpei× Hosogaya, Naoki× Fukushima, Chizu× Yamamoto, Hiroshi× Kawakami, Atsushi |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Background:Colchicine is the first-line treatment for familial Mediterranean fever (FMF), but secondary amyloidosis resulting from persistent inflammation is a concern in patients with colchicine-resistant or colchicine-intolerant FMF. Although tocilizumab (TCZ), which is a recombinant, humanized, anti-human interleukin 6 receptor monoclonal antibody, has been reported to prevent FMF attacks, the long-term safety and efficacy of TCZ on individuals with colchicine-resistant or colchicine-intolerant FMF have not been evaluated.Methods/design:In this investigator-initiated, multicenter, open-label trial, the long-term safety of TCZ will be evaluated in patients participating in a placebo-controlled, randomized, double-blind, parallel-group trial on colchicine-resistant or colchicine-intolerant FMF. The study will be conducted in 9 centers in Japan. After the evaluation and examination for 24 weeks in the preceding study, this trial will be started promptly. The trial will be completed by the time the drug is approved for FMF treatment in Japan. The primary endpoint is the incidence of adverse events, and the secondary endpoints include the number of FMF attacks, number of occurrences of accompanying symptoms during attacks, serum C-reactive protein and amyloid A levels, general evaluation by a physician (100mm visual analog scale [VAS]), general evaluation by a patient (100mm VAS), and body temperature.Discussion:The study is expected to obtain evidence regarding the long-term safety of TCZ as a potential new therapeutic agent for patients with colchicine-resistant or colchicine-intolerant FMF.Trial registration:This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (https://upload.umin.ac.jp/cgi-open-bin/ctr-e/ctr-view.cgi?recptno=R000037116) as UMIN000032557 on May 30 2018. | |||||
書誌情報 |
Medicine 巻 99, 号 1, p. e18328, 発行日 2020-01 |
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出版者 | ||||||
出版者 | Wolters Kluwer Health, Inc. | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 00257974 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1097/MD.0000000000018328 | |||||
権利 | ||||||
権利情報 | c 2020 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | Medicine, 99(1), e18328; 2020 |