Dementia, Alzheimer Disease
Conditions
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.
Interventions
DRUGMethotrexate
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.
DRUGAnti-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.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed