臨床研究等提出・公開システム

Japanese

Date of registration	April. 28, 2025
Last modified on	April. 28, 2025
Trial ID	jRCT1030250036

Scientific Title	Epidemiology and Treatment Trends of Rheumatoid Arthritis with Dementia in Japan: A Nationwide Claims Database Study
Public Title	Epidemiology and Treatment Trends of Rheumatoid Arthritis with Dementia in Japan: A Nationwide Claims Database Study

Contact for Scientific Queries	Name	Tada Masahiro
	Affiliation	Department of Orthopaedic Surgery, Osaka City General Hospital
	Address	2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka, Japan,
	Telephone	+81-6-6929-1221
	E-mail	m-tada@omu.ac.jp
Contact for Public Queries	Name	Fujimoto Keita
	Affiliation	Eisai Co., Ltd.,
	Address	4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088 , Japan,
	Telephone	+81-90-6749-5344
	E-mail	k3-fujimoto@hhc.eisai.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 28, 2025
Actual date of first enrollment
Target sample size		450000
Study Type		Other
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients had to fulfill all of the following criteria to be included in the study: aged >=65 years at the time of RA diagnosis between 1 January 2015 and 31 December 2023 (ICD-10 codes M05, M060, M062, M063, M068, M069, excluding RS3PE syndrome [standard injury code: 8844120], wrist deformity [standard injury code: 8845190], and ulnar deviation [standard injury code: 8845158]); with at least one prescription for a DMARD or oral glucocorticoid within 1 year of the first RA diagnosis; and with a record of data in the DeSC database for at least 180 days prior to the index date.
	Exclusion Criteria	No exclusion criteria were set for the primary study endpoint. For secondary endpoints, individuals who lacked prescription records for DMARDs or oral corticosteroids within 1 year of the index date were excluded.
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		rheumatoid arthritis
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		C05.550.114.154, C05.799.114, C17.300.775.099, C20.111.199
Intervention(s) Code
Primary Outcome(s)		The primary endpoint was the prevalence of dementia by year (2015-2023) in all patients with RA aged >=65 years.
Secondary Outcome(s)		The secondary endpoints were: annual incidence of dementia in patients with RA aged 65-74 and >=75 years, status of DMARD prescriptions in patients with RA aged 65-74 and >=75 years who developed dementia, and survival time analysis for new prescriptions or increased doses of oral glucocorticoids in patients aged 65-74 and >=75 years who developed dementia.

Primary Sponsor	Eisai Co., Ltd.,

Source of Monetary Support / Secondary Sponsor	Eisai Co., Ltd.,
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Reseach Instiute of Healthcare Data Science
Address	2-5-5 Daimonn, Minato-ku, Tokyo, Japan,, Tokyo
Telephone	+81-3-5733-5010
E-Mail	rihds@jmdc.co.jp
Approval Status	Approval
Date of approval	Nov. 27, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none