A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Alzheimer Disease; Dementia

Treatments: Drug: Methotrexate; Drug: Anti-TNF

Study type: Observational

Funder types: Industry

Identifiers

NCT04571697

CR108890

PCSNSP002938 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to compare the risk of dementia in participants diagnosed with rheumatoid arthritis (RA) exposed to anti-tumor necrosis factor (TNF) therapy versus those exposed to methotrexate.

Enrollment: 34,647 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• At least one claim for methotrexate or anti-TNF therapy during the study period. First medication received is the index medication, and date of first receipt is the index date
• 365 days of continuous pre-index observation immediately prior to the index date
• Participants have at least two occurrences of a diagnosis of rheumatoid arthritis within 365 days before and including the index date
• No prior use of methotrexate or an anti- tumor necrosis factor (TNF) therapy at any time prior to the index date
• Cohort follow-up persists until end of continuous observation or filling the comparator drug

Trial design

34,647 participants in 1 patient group

Participants Initiating Therapy with Methotrexate or Anti-TNF

Description:

Data will be collected for participants initiating therapy with either methotrexate or an anti-tumor necrosis factor (TNF) from united states (US) claims databases: optum de-identified clinformatics data mart database and IBM marketscan medicare supplemental database (MDCR). Data collection period: 01-Jan-2000 through 31-Jul2019.

Treatment:

Drug: Anti-TNF

Drug: Methotrexate