Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- relapse rate of inflammation
研究概览
简要总结
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.
详细描述
TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of non-infectious uveitis
- •nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy
- •Family members and patients who are willing to stop should agree and accept relevant examinations
- •The informed consent is read and signed by the patient or a legally authorized represent
排除标准
- •Unwilling to sign informed consent
- •There is systemic autoimmune disease uncontrolled situation
- •Patients who may require surgery in the near future
- •Vision meets the standards of low vision and blindness
- •Silicone oil or gas filling after vitreous surgery
结局指标
主要结局
relapse rate of inflammation
时间窗: 24 months
The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation
次要结局
- macular structure(24 months)
- Best corrected visual Acuity(24 months)
研究者
Dan Liang
PhD
Sun Yat-sen University