Comparing Rates of Dementia and Alzheimer's Disease in Patients Initiating Methotrexate Versus Those Initiating Anti-TNF-α Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,647
- 试验地点
- 1
- 主要终点
- Newly Diagnosed Dementia Cases
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Methotrexate (Drug)
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.
干预措施: Anti-TNF (Drug)
结局指标
主要结局
Newly Diagnosed Dementia Cases
时间窗: 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.
次要结局
- Newly Diagnosed Alzheimer's Disease (AD) Cases(365 days)