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

Completed

• Conditions: Dementia; Alzheimer Disease
• Interventions: Drug: Methotrexate; Drug: Anti-TNF

• Registration Number: NCT04571697
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Study Start: 2020-09-28
• Study First Posted: 2020-10-01
• Primary Completion: 2020-10-27
• Study Completion: 2020-10-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34647

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Initiating Therapy with Methotrexate or Anti-TNF	Anti-TNF	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.
Participants Initiating Therapy with Methotrexate or Anti-TNF	Methotrexate	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.

Primary Outcome Measures

Name	Time	Method
Newly Diagnosed Dementia Cases	365 days	An outcome of dementia requires at least two diagnosis codes international classification of diseases, ninth revision, clinical modification (ICD-9-CM) or international classification of diseases, tenth revision, clinical modification (ICD-10-CM) for dementia within 365 days of each other.

Secondary Outcome Measures

Name	Time	Method
Newly Diagnosed Alzheimer's Disease (AD) Cases	365 days	An outcome of AD requires at least two diagnosis codes (ICD-9-CM or ICD-10-CM) for AD within 365 days of each other.

Trial Locations

Locations (1)

Janssen R&D; 🇺🇸 Titusville, New Jersey, United States