Clinical trial · Observational
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
NCT04571697CI-TRIAL-00088980completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-TNF | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Methotrexate
- Drug: Anti-TNF
Primary outcomes (1)
- measure
- Newly Diagnosed Dementia Cases
- timeFrame
- 365 days
- description
- 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 outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.