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

Completed

• Conditions: rheumatoid arthritis

• Registration Number: jRCT1030250036
• Lead Sponsor: Eisai Co., Ltd.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Last Update Posted: 2025-04-28

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 450000

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.

Study & Design

• Study Type: Other
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
prevalence of dementia	2015-2023	The prevalence of dementia in all patients with RA aged >=65 years

Secondary Outcome Measures

Name	Time	Method
annual incidence of dementia in patients with RA aged 65-74 and >=75 years	annual	Annual incidence of dementia in patients with rheumatoid arthritis (RA) aged 65-74 and ≥75 years.
status of DMARD prescriptions in patients with RA aged 65-74 and >=75 years who developed dementia		Status of disease-modifying antirheumatic drug (DMARD) prescriptions in patients with RA aged 65-74 and ≥75 years who developed dementia.
survival time analysis for new prescriptions or increased doses of oral glucocorticoids in patients aged 65-74 and >=75 years who developed dementia		Survival time analysis for new prescriptions or increased doses of oral glucocorticoids in patients aged 65-74 and ≥75 years who developed dementia.