Late-onset rheumatoid arthritis registry study, LORIS study: study protocol and design

Masayo Kojima, Yutaka Kawahito, Takahiko Sugihara, Toshihisa Kojima, Ryozo Harada, Shintaro Hirata, Motomu Hashimoto, Toshihiko Hidaka, Hajime Ishikawa, Hiromu Ito, Mitsumasa Kishimoto, Yuko Kaneko, Kazuo Matsui, Toshihiro Matsui, Isao Matsushita, Akio Morinobu, Keiichiro Nishida, Eiichi Tanaka, Asami Abe, Michinori IshitokuShuji Asai, Takashi Kida, Akira Onishi, Satoshi Takanashi, Masayoshi Harigai

Research output: Contribution to journalArticlepeer-review


Background: Although drug treatment strategies for rheumatoid arthritis (RA) are relatively well established, there is a paucity of evidence on the treatment in older patients. 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. Methods/design: 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 ≥ 65 years at onset, meeting 2010 ACR/EULAR classification criteria for RA, and starting either any disease-modifying antirheumatic drugs (DMARDs) in a DMARD-naïve 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. Discussion: 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. Study registration: Registered at the UMIN registry (UMIN000046086) on 1 January 2022.

Original languageEnglish
Article number90
JournalBMC Rheumatology
Issue number1
Publication statusPublished - 2022 Dec


  • Biologics
  • Elderly onset
  • Frailty
  • MTX
  • Patient and public involvement
  • Prospective study

ASJC Scopus subject areas

  • Rheumatology


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