{"created":"2023-05-15T16:49:00.868209+00:00","id":26272,"links":{},"metadata":{"_buckets":{"deposit":"8e797484-247c-4d64-9fbe-557b0c166594"},"_deposit":{"created_by":6,"id":"26272","owners":[6],"pid":{"revision_id":0,"type":"depid","value":"26272"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00026272","sets":["10:11"]},"author_link":["112292","112290","112287","112295","112296","112288","112293","112289","112291","112294"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2020-12-11","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"50","bibliographicPageStart":"e23291","bibliographicVolumeNumber":"99","bibliographic_titles":[{"bibliographic_title":"Medicine"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"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.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"Medicine, 99(50), e23291; 2020","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"Wolters Kluwer Health, Inc."}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1097/MD.0000000000023291","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"©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."}]},"item_2_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0025-7974","subitem_source_identifier_type":"ISSN"}]},"item_2_version_type_16":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Koga, Tomohiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Takemori, Sachiko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Hagimori, Naoko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Morimoto, Shimpei"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sumiyoshi, Remi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shimizu, Toshimasa"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Hosogaya, Naoki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Fukushima, Chizu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yamamoto, Hiroshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kawakami, Atsushi"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2021-01-22"}],"displaytype":"detail","filename":"Medicine99_23291.pdf","filesize":[{"value":"337.5 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"Medicine99_23291.pdf ","url":"https://nagasaki-u.repo.nii.ac.jp/record/26272/files/Medicine99_23291.pdf"},"version_id":"4641528d-f7fb-48fe-a943-9c6b634038bc"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman disease","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman disease"}]},"item_type_id":"2","owner":"6","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2021-01-22"},"publish_date":"2021-01-22","publish_status":"0","recid":"26272","relation_version_is_last":true,"title":["An open-label continuation trial of sirolimus for tocilizumab-refractory idiopathic multicentric Castleman disease"],"weko_creator_id":"6","weko_shared_id":-1},"updated":"2023-05-15T22:55:25.300445+00:00"}