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临床试验/NCT06821971
NCT06821971进行中(未招募)不适用

Study of Risk Factors for Therapeutic Failure in Chronic Non-Infectious Uveitis After First-Line Immunosuppressive Therapy

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
1
主要终点
Number of therapeutic failure at 4 months

研究概览

简要总结

Uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . It is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. In the case of cortico-dependence, it is generally accepted to propose sparing with a conventional immunosuppressant, whose efficacy is estimated at around 70%, compared with biotherapies, which are considered more effective (over 90%) but only available as 2nd-line treatment. However, there are few studies on the failure factors of this first-line treatment, such as macular thickness , gender, or vitamin D deficiency. Risk factors for flare-ups are nevertheless known, notably ethnicity, and smoking. The aim of this study is to identify risk factors for treatment failure after three months of first-line immunosuppressive therapy in patients with chronic non-infectious uveitis at Amiens-Picardie University Hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age : > 18 years old
  • Uveitis requiring immunosuppressive therapy.
  • Including at least one posterior involvement according to the SUN terminology: posterior, or intermediate and posterior, or anterior and posterior, or panuveitis.

排除标准

  • Uveitis associated with multiple sclerosis or systemic lupus erythematosus.
  • Ocular involvement in Behcet's disease requiring biologic therapy as first-line immunosuppressive treatment.
  • Uveitis without posterior segment involvement.
  • Infectious uveitis.
  • Patients objecting to the use of their personal data for research purposes.

结局指标

主要结局

Number of therapeutic failure at 4 months

时间窗: 4 months

Therapeutic failure at 4 months following the initiation of a first-line immunosuppressant in patients with chronic non-infectious uveitis (CNIU).

次要结局

  • Number of therapeutic failure at 9 months(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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