Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,732
- 试验地点
- 1
- 主要终点
- Withdrawal rate due to major / serious adverse events
研究概览
简要总结
This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.
详细描述
This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All RA patients in our biologics registry treated with the JAK inhibitors (N=411)
- •All RA patients in our biologics registry treated with the TNF inhibitors (N=1392)
排除标准
- •RA patients in our biologics registry treated with other biologic/targeted DMARDs
研究组 & 干预措施
JAK inhibitors
RA patients treated with JAK inhibitors
干预措施: biologic/targeted therapy (Drug)
TNF inhibitors
RA patients treated with TNF inhibitors
干预措施: biologic/targeted therapy (Drug)
结局指标
主要结局
Withdrawal rate due to major / serious adverse events
时间窗: from start of biologic/targeted DMARD use to these event(s) up to 10 years
adverse events eg. MACEs, malignancy, infections
次要结局
- Withdrawal rate due to inefficacy(from start of biologic/targeted DMARD use to last clinic visit up to 10 years)
研究者
Chi Chiu Mok
Consultant
Tuen Mun Hospital