{"created":"2023-05-15T16:30:24.487354+00:00","id":1522,"links":{},"metadata":{"_buckets":{"deposit":"2766d002-e481-4bdb-af3b-b2fa3de4713d"},"_deposit":{"created_by":2,"id":"1522","owners":[2],"pid":{"revision_id":0,"type":"depid","value":"1522"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00001522","sets":["10:11"]},"author_link":["7294","7293","7295","7292","7296","7297","7291","7299","7298"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2018-12-29","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageEnd":"715","bibliographicVolumeNumber":"19","bibliographic_titles":[{"bibliographic_title":"Trials"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Background: Familial Mediterranean fever (FMF) is an inherited disorder caused by a number of mutations of the Mediterranean\n fever (MEFV) gene, coding a protein named pyrin that acts as a major regulatory component of the inflammasome.The first-line drug for FMF treatment is colchicine, but 10% of patients with FMF do not respond well to colchicine.Although the efficacy of tocilizumab (TCZ), which is a recombinant, humanized, antihuman interleukin 6 (IL-6) receptor monoclonal antibody, has been reported to prevent FMF attacks, the effects of TCZ on individuals with colchicine-resistant or colchicine-intolerant FMF have not been evaluated in a randomized clinical trial. Methods/design: In this phase III, \ninvestigator-initiated, multicenter, double-blind, randomized, parallel-group trial, \nthe efficacy and safety of TCZ will be compared with placebo in patients with colchicine-resistant or colchicine-intolerant FMF. The study will be conducted in nine centers in Japan. Participants (n = 24) will be randomly assigned to receive 162 mg of TCZ (n = 12) or placebo (n = 12) administered subcutaneously once weekly for 24 weeks. Rescue treatment will be allowed if rescue criteria are met. A primary endpoint is the number of fever attacks until 24 weeks.Secondary endpoints include the number of occurrences of accompanying symptoms during attacks; the time until a fever attack occurs; the duration of fever attacks; serum C-reactive protein and serum amyloid A;36-item Short Form Health Survey; general evaluation by a physician (100-mm visual analogue scale); body temperature;\n the percentage of subjects who achieve FMF 50 at 12 weeks and 24 weeks; and pharmacodynamic assessment, including the measurement of serum TCZ level and soluble IL-6 receptor. Discussion: The study is expected to produce evidence regarding the efficacy of a potential new therapeutic agent, TCZ, in improving the clinical course and outcome for patients with colchicine-resistant or colchicine-intolerant FMF. \nTrial registration: University Hospital Medical Information Network Clinical Trials Registry, UMIN000028010. Registered on 7 July 2017.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"Trials, 19(1), art.no.715; 2019","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"BioMed Central Ltd."}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1186/s13063-018-3105-6","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"c The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and\nreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver\n(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, \nunless otherwise stated."}]},"item_2_source_id_8":{"attribute_name":"EISSN","attribute_value_mlt":[{"subitem_source_identifier":"17456215","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":"Sato, Shuntaro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Miyamoto, Junya"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Hagimori, Naoko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kawazoe, Yurika"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Arinaga, Kumiko"}],"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":"2020-12-18"}],"displaytype":"detail","filename":"Trials19_715.pdf","filesize":[{"value":"940.6 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"Trials19_715.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/1522/files/Trials19_715.pdf"},"version_id":"006dd3d4-2091-4694-b91c-3af744d56b03"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Colchicine-resistant","subitem_subject_scheme":"Other"},{"subitem_subject":"FMF","subitem_subject_scheme":"Other"},{"subitem_subject":"IL-6","subitem_subject_scheme":"Other"},{"subitem_subject":"Placebo","subitem_subject_scheme":"Other"},{"subitem_subject":"Tocilizumab","subitem_subject_scheme":"Other"}]},"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":"Comparison of the efficacy and safety of tocilizumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: study protocol for an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Comparison of the efficacy and safety of tocilizumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: study protocol for an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial"}]},"item_type_id":"2","owner":"2","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2019-01-23"},"publish_date":"2019-01-23","publish_status":"0","recid":"1522","relation_version_is_last":true,"title":["Comparison of the efficacy and safety of tocilizumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: study protocol for an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial"],"weko_creator_id":"2","weko_shared_id":-1},"updated":"2023-05-16T04:01:00.245120+00:00"}