Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,557
- 主要终点
- Percentage of participants with pulmonary arterial hypertension
研究概览
简要总结
This study is designed to analyze the frequency and incidence rate of pulmonary complications in JIA participants who received biological DMARDs and non-biologic DMARDs. The participants having evidence of of a prescription or administration of one of the biologic or non-biologic DMARDs will be included in five different treatment groups. Data from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases will be used to estimate the incidence rate of pulmonary complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with less than (<) 18 years of age at index
- •Continuously enrolled for greater than (>) 6 months prior to index (baseline period)
- •One diagnosis of JIA (714.3) on a non-diagnostic claim either during the baseline period (the complete participant record prior to the episode index will be defined as the episode baseline period) or within the first 30 days following the index date
- •Had both medical and pharmacy benefit plus complete data availability during both baseline and follow-up periods
排除标准
- •For biologic DMARD cohorts, prior use of any qualifying biologic belonging to the biologic DMARD of interest (using all available claims history)
- •For non-biologic DMARD cohort, prior use of any non-biologic DMARD or biologic DMARD
- •Any record of rituximab use in complete participant record
- •A prior safety event during the baseline period
研究组 & 干预措施
Biologic DMARDs
Participants who received biologic DMARDs as per standard of care were included in this arm.
干预措施: Biological DMARDs (Drug)
Non-biological DMARDs
Participants who received non-biologic DMARDs as per standard of care were included in this arm.
干预措施: Non-Biologic DMARDs (Drug)
结局指标
主要结局
Percentage of participants with pulmonary arterial hypertension
时间窗: up to the end of the study (up to overall period of 12 years)
次要结局
- Percentage of participants with interstitial lung disease(up to the end of study (up to overall period of 12 years))
- Percentage of participants with alveolar proteinsis(up to the end of study (approximately 2.2 years))
- Percentage of participants with lipoid pneumonia(up to the end of study (up to overall period of 12 years))
- Percentage of participants with pulmonary hypertension(up to the end of study (up to overall period of 12 years))
- Percentage of participants with overall composite pulmonary complications(up to the end of study (up to overall period of 12 years))