WEKO3
アイテム
{"_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": ["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": [{"nameIdentifier": "7291", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Sato, Shuntaro"}], "nameIdentifiers": [{"nameIdentifier": "7292", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Miyamoto, Junya"}], "nameIdentifiers": [{"nameIdentifier": "7293", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Hagimori, Naoko"}], "nameIdentifiers": [{"nameIdentifier": "7294", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Kawazoe, Yurika"}], "nameIdentifiers": [{"nameIdentifier": "7295", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Arinaga, Kumiko"}], "nameIdentifiers": [{"nameIdentifier": "7296", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Fukushima, Chizu"}], "nameIdentifiers": [{"nameIdentifier": "7297", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Yamamoto, Hiroshi"}], "nameIdentifiers": [{"nameIdentifier": "7298", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Kawakami, Atsushi"}], "nameIdentifiers": [{"nameIdentifier": "7299", "nameIdentifierScheme": "WEKO"}]}]}, "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", "download_preview_message": "", "file_order": 0, "filename": "Trials19_715.pdf", "filesize": [{"value": "940.6 kB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensetype": "license_free", "mimetype": "application/pdf", "size": 940600.0, "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"], "permalink_uri": "http://hdl.handle.net/10069/38788", "pubdate": {"attribute_name": "公開日", "attribute_value": "2019-01-23"}, "publish_date": "2019-01-23", "publish_status": "0", "recid": "1522", "relation": {}, "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_shared_id": -1}
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
http://hdl.handle.net/10069/38788
http://hdl.handle.net/10069/38788420a32e6-54d5-438b-a083-2807288b91ff
名前 / ファイル | ライセンス | アクション |
---|---|---|
Trials19_715.pdf (940.6 kB)
|
|
Item type | 学術雑誌論文 / Journal Article(1) | |||||
---|---|---|---|---|---|---|
公開日 | 2019-01-23 | |||||
タイトル | ||||||
タイトル | 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 | |||||
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 | Placebo | |||||
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× Sato, Shuntaro× Miyamoto, Junya× Hagimori, Naoko× Kawazoe, Yurika× Arinaga, Kumiko× Fukushima, Chizu× Yamamoto, Hiroshi× Kawakami, Atsushi |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Background: Familial Mediterranean fever (FMF) is an inherited disorder caused by a number of mutations of the Mediterranean 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, investigator-initiated, multicenter, double-blind, randomized, parallel-group trial, the 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; 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. Trial registration: University Hospital Medical Information Network Clinical Trials Registry, UMIN000028010. Registered on 7 July 2017. |
|||||
書誌情報 |
Trials 巻 19, 号 1, p. 715, 発行日 2018-12-29 |
|||||
出版者 | ||||||
出版者 | BioMed Central Ltd. | |||||
EISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 17456215 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1186/s13063-018-3105-6 | |||||
権利 | ||||||
権利情報 | 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 reproduction 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 (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
|||||
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 | Trials, 19(1), art.no.715; 2019 |