NCT04571697

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

Comparing Rates of Dementia and Alzheimer's Disease in Patients Initiating Methotrexate Versus Those Initiating Anti-TNF-α Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34,647 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Methotrexate	No intervention or treatment will be administered as part of this study. Data of participants with first claim for a methotrexate in the patient's history are included.
DRUG	Anti-TNF	No intervention or treatment will be administered as part of this study. Data of participants with first claim for an anti-TNF in the patient's history are included. Anti-TNF includes infliximab, golimumab, etanercept, certolizumab, and adalimumab.

Timeline

• Start date: 2020-09-28
• Primary completion: 2020-10-27
• Completion: 2020-10-27
• First posted: 2020-10-01
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study