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| ID | Type | Description | Link |
|---|---|---|---|
| PCSNSP002938 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Newly Diagnosed Dementia Cases | 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. | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Newly Diagnosed Alzheimer's Disease (AD) Cases | 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. | 365 days |
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Inclusion Criteria:
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Study population consists of participants who are new user of Anti-TNF therapy diagnosed with dementia and alzheimer's disease.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen R&D | Titusville | New Jersey | 08560 | United States |
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| Anti-TNF | Drug | 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. |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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