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
NCT ID: NCT04571697
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34647 participants
OBSERVATIONAL
2020-09-28
2020-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants Initiating Therapy with Methotrexate or 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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Janssen R&D
Titusville, New Jersey, United States
Countries
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Other Identifiers
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PCSNSP002938
Identifier Type: OTHER
Identifier Source: secondary_id
CR108890
Identifier Type: -
Identifier Source: org_study_id
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