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The purpose of this study is to build a registry for late-onset RA (LORA), which is expected to increase rapidly worldwide. In addition, we aim to propose optimal treatment strategies according to the patient background including frailty, thereby contributing to improving the quality of treatment and daily living in patients with RA.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods\/design<\/jats:title>\n                <jats:p>The LORIS (Late-onset Rheumatoid Arthritis Registry) Study is a prospective nation-wide multicenter observational study of patients with LORA. The inclusion criteria were patients aged\u2009\u2265\u200965\u00a0years at onset, meeting 2010 ACR\/EULAR classification criteria for RA, and starting either any disease-modifying antirheumatic drugs (DMARDs) in a DMARD-na\u00efve patient or the first biologic\/targeted synthetic DMARDs during the study period. Enrollment was started on 11 January, 2022 and will be closed on 31 December, 2023. Patients will undergo a comprehensive baseline assessment including clinical data, medication, cognitive and physical function, psychosocial factors, and frailty. Data will be collected at baseline, Month 3, 6, 12, 18, 24, 36, and summarized descriptively. The factors associated with adverse events and achieving remission will be determined.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>A multi-disciplinary panel including patients, rheumatologists, and geriatric specialists will discuss the results and build a consensus regarding the treatment goals of LORA. We expect to provide a broad range of information for evidence-based shared decision making in the treatment of LORA.<\/jats:p>\n                <jats:p><jats:italic>Study registration<\/jats:italic>: Registered at the UMIN registry (UMIN000046086) on 1 January 2022.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41927-022-00322-7","type":"journal-article","created":{"date-parts":[[2022,12,26]],"date-time":"2022-12-26T01:02:17Z","timestamp":1672016537000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Late-onset rheumatoid arthritis registry study, LORIS study: study protocol and design"],"prefix":"10.1186","volume":"6","clinical-trial-number":[{"clinical-trial-number":"umin000046086","registry":"10.18810\/umin-japan"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8946-1131","authenticated-orcid":false,"given":"Masayo","family":"Kojima","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Kawahito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiko","family":"Sugihara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihisa","family":"Kojima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryozo","family":"Harada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shintaro","family":"Hirata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motomu","family":"Hashimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiko","family":"Hidaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajime","family":"Ishikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromu","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsumasa","family":"Kishimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Kaneko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuo","family":"Matsui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Matsui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isao","family":"Matsushita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akio","family":"Morinobu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichiro","family":"Nishida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiichi","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asami","family":"Abe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michinori","family":"Ishitoku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuji","family":"Asai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Kida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Onishi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Takanashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayoshi","family":"Harigai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,12,26]]},"reference":[{"key":"322_CR1","doi-asserted-by":"publisher","first-page":"941","DOI":"10.1080\/14397595.2019.1682776","volume":"30","author":"M Kojima","year":"2020","unstructured":"Kojima M, Nakayama T, Tsutani K, Igarashi A, Kojima T, Suzuki S, et al. 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Each researcher conducts the study after obtaining research implementation approval from their affiliated institution. Researchers hand the informed consent form to candidates for enrollment, and obtain their written consent for voluntary participation in the study. Signature by proxy is allowed, but consent by proxy is not permitted.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Study participants are informed that their anonymized data will be published in academic journals and provide the written consent form for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"In the circumstance of conflict of interest (COI) relating to this study, the researchers have reported it to their respective institutions according to regulations stipulated by JCR and their institution as follows; Yutaka Kawahito has received speaking fees from Asahi-Kasei, Astellas, Eli Lilly, Daiichi-Sankyo, Bristol-Myers Squibb, Janssen, and has scholarship grant and clinical trial fees from AbbVie, and has speaker fees, scholarship grant and clinical trial fees from Eisai, and has speaker fees and scholarship grant from Chugai. Takahiko Sugihara has received research funds and scholarship grant from Chugai, Ono Pharmaceutical Co., Ltd., UCB, CSL Behring K.K., Ayumi Pharmaceutical Corporation, Japan Blood Products Organization, AbbVie, Nippon Kayaku, Asahi-Kasei. Toshihisa Kojima has received research funding from AbbVie, Eli Lilly, Chugai, Astellas, and has received speaking fees from Chugai, Pfizer, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Astellas. Shintaro Hirata has received research grants from AbbVie, Asahi-Kasei, Eisai, Otsuka Pharmaceutical Co., Ltd., Sanofi, Shionogi, Chugai, Pfizer, Mitsubishi-Tanabe, Eli Lilly, UCB, and has receives consulting fees from AbbVie, Astellas, Eisai, Gilead Sciences, Eli Lilly, Bristol-Myers Squibb, and has received speaking fees from AbbVie, Asahi-Kasei, Astellas, Ayumi Pharmaceutical Corporation, Bristol-Myers Squibb, Celgene Corporation, Chugai, Eisai, Gilead Sciences, Glaxo Smith Kline, Eli Lilly, Janssen, KYORIN Pharmaceutical Co., Ltd., Novartis, Pfizer, Sanofi, Mitsubishi-Tanabe, UCB. Motomu Hashimoto has received research grants from AbbVie, Asahi-Kasei, Astellas, Bristol Myers Squibb, Eisai Daiichi-Sankyo, Eli Lilly, Novartis, and has received speaking fees from Eli Lilly, Chugai, Mitsubishi-Tanabe, Bristol Myers Squibb, Eisai. Toshihiko Hidaka has received speaking fees from Pfizer, Astellas, Bristol Myers Squibb, AbbVie, Eisai, Asahi-Kasei, Eli Lilly. Hajime Ishikawa has received speaker and writing fees from Chugai, Bristol-Myers Squibb. research funding and scholarship grant from IQVIA, Corronal LLC, Eli Lilly, Eisai, Gilead Sciences. Hiromu Ito has received research funding from Bristol Myers Squibb, Eisai, Taisho, Mochida Pharmaceutical Plant Co., Ltd. Mitsumasa Kishimoto has received speaking fees from Chugai, Pfizer, AbbVie, Mitsubishi-Tanabe, Eisai, Eli Lilly, Daiichi-Sankyo, Astellas, Ayumi Pharmaceutical Corporation, Ono Pharmaceutical Co., Ltd., Asahi-Kasei, Janssen, Amgen K.K., Gilead Sciences, UCB, Bristol Myers Squibb, Novartis. Yuko Kaneko has received research grants from AbbVie, Eisai, Sanofi, Chugai, Mitsubishi-Tanabe, Taisho, and has received scholarship grant from Asahi-Kasei, Eisai, Boehringer Ingelheim, Taisho, and has received speaking fees from AbbVie, Asahi-Kasei, Astellas, Ayumi Pharmaceutical Corporation, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Glaxo Smith Kline, Novartis, Pfizer, Janssen, UCB, Gilead Sciences. Toshihiro Matsui has received speaker fees from Eli Lilly, Chugai, Ono Pharmaceutical Co., Ltd. and has research funding from Astellas, Glaxo Smith Kline, AbbVie, and has scholarship grant from Chugai, Asahi-Kasei. Isao Matsushita has received lecture fees from Mitsubishi-Tanabe, Astellas, Bristol-Myers Squibb, Chugai. Akio Morinobu has received research funding from AbbVie, Asahi-Kasei, Chugai, Ono Pharmaceutical Co., Ltd., and has received speaking fees from Eli Lilly, AbbVie, Ono Pharmaceutical Co., Ltd., Pfizer, Astellas, Chugai, Eisai Bristol-Myers Squibb. Keiichiro Nishida has received speaking fees from Asahi-Kasei, Mitsubishi-Tanabe, Chugai, Eli Lilly, Ono Pharmaceutical Co., Ltd., Daiichi-Sankyo, Gilead Sciences, AbbVie, Janssen and has received scholarship grant from Chugai. Eiichi Tanaka has received speaking fees and consulting fees from AbbVie, Asahi-Kasei, Astellas, Ayumi Pharmaceutical Corporation, Bristol-Myers Squibb, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Glaxo Smith Kline, Kyowa Pharma chemical, Janssen, Mitsubishi-Tanabe, Mochida Pharmaceutical Plant Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer, Takeda, Teijin Nakashima Medical Co., Ltd., UCB. Shuji Asai has received speaking fees from AbbVie, Asahi Kasei, Astellas, Bristol-Myers Squibb, Chugai, Eli Lilly, Pfizer, and Sanofi. Takashi Kida has received speaking fees from Chugai, Eisai, Janssen. Akira Onishi has received grants from Pfizer Inc., Bristol-Myers Squibb., Ayumi, the Health Care Science Institute, and Advantest, and speaking fees from Asahi Kasei Pharma, Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K, Ono Pharmaceutical Co., Mitsubishi Tanabe Pharma, Eisai Co. Ltd., Abbvie Inc., Takeda Pharmaceutical Company Limited, and Daiichi Sankyo Co. Ltd. Satoshi Takanashi received speaking fees from Asahi-Kasei, Astellas, Bristol-Myers Squibb, Eisai. Masayoshi Harigai has received research grants from AbbVie, Asahi-Kasei, Astellas, Ayumi Pharmaceutical Corporation, Bristol-Myers Squibb, Chugai, Eisai, Mitsubishi-Tanabe, Nippon Kayaku, and Taisho, and has receives consulting fees from AbbVie, Bristol-Myers Squibb, and has received speaker fees, AbbVie, Mitsubishi-Tanabe, Chugai, Eli Lilly. All other authors have declared no conflicts of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"90"}}