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An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman disease
http://hdl.handle.net/10069/00040475
http://hdl.handle.net/10069/0004047517438701-54d7-42d0-b2a4-967abdf5fd64
名前 / ファイル | ライセンス | アクション |
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Medicine99_23291.pdf (337.5 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2021-01-22 | |||||
タイトル | ||||||
タイトル | An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman disease | |||||
言語 | ||||||
言語 | eng | |||||
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× Takemori, Sachiko× Hagimori, Naoko× Morimoto, Shimpei× Sumiyoshi, Remi× Shimizu, Toshimasa× 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: Interleukin 6 (IL-6) inhibitors are the first-line treatment for idiopathic multicentric Castleman disease (iMCD); however, there is no established treatment for cases that are resistant to IL-6 inhibitors. Although sirolimus, a mammalian target of rapamycin inhibitor, has been suggested to be effective in patients with iMCD, the long-term safety and efficacy of sirolimus on individuals with IL-6 inhibitor-resistant iMCD have not been evaluated. METHODS/DESIGN: In this investigator-initiated, multicenter, open-label trial, the long-term safety of sirolimus will be evaluated in patients pating in a placebo-controlled, randomized, double-blind, parallel-group trial on tocilizumab (TCZ)-resistant iMCD. The study will be conducted in 7 centers in Japan. This trial will be promptly started after the evaluation and examination for 16 weeks in the preceding study. The trial will be completed by the time the drug is approved for iMCD treatment in Japan. The primary endpoint is the incidence of adverse events. The secondary endpoints include the following: the levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; physician global assessment (100-mm visual analog scale); patient global assessment (100-mm visual analog scale); and lymph node changes in subjects with lymphadenopathy. DISCUSSION: This clinical trial will provide evidence regarding the long-term safety of sirolimus as a potential novel therapeutic agent for patients with tocilizumab-resistant iMCD. TRIAL REGISTRATION NUMBER: jRCT2051200050. | |||||
書誌情報 |
Medicine 巻 99, 号 50, p. e23291, 発行日 2020-12-11 |
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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 | 0025-7974 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1097/MD.0000000000023291 | |||||
権利 | ||||||
権利情報 | ©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 inany 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(50), e23291; 2020 |