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 studied: Dementia, Alzheimer Disease
In brief
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.
Key facts
- Study ID
- NCT04571697
- Run by
- Janssen Research & Development, LLC
- People needed
- 34647
- Starts
- 2020-09-28
- Expected to finish
- 2020-10-27
- Last updated by the study team
- 2025-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Janssen R&D — Titusville, New Jersey, United States
Full record on ClinicalTrials.gov
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