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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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
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Participants have at least two occurrences of a diagnosis of rheumatoid arthritis within 365 days before and including the index date
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Janssen R&D | Titusville | New Jersey | United States | 08560 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108890
- PCSNSP002938