NCT05651880尚未招募3 期
Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of patients with complete remission
研究概览
简要总结
The aim of the study is to evaluate the efficacy of Baricitinib, a JAK1 and 2 inhibitor, in the management of non-infectious non-anterior uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) after 6 months of treatment
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab)
- •Need to stop biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressive drugs (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date
排除标准
- •1. Isolated anterior uveitis.
- •Infectious uveitis.
- •Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids.
- •4. Initial visual acuity > 1.3 LogMAR in at least one eye.
- •Corneal or lens opacity that prevents fundus visualization or may require cataract surgery during the study.
- •6. Contraindication to baricitinib (OLUMIANT 2 and 4 mg film-coated tablets) : Hypersensitivity to the active substance or to any of the excipients.
- •7. Contraindication to mydriasis.
- •Refractory glaucoma in either eye.
- •Monophthalmic patient.
- •Previous treatment with JAK inhibitors.
- •Intraocular corticosteroid injection (subconjunctival or laterobulbar) within 1 month prior to inclusion or intravitreal corticosteroid implant within 3 months prior to inclusion.
- •12. Need for treatment with a biotherapy (anti-IL6, anti-IL6 receptor, anti-IL1, anti-IL12/IL23 anti-IL17, anti-BAFF) for extra-ocular involvement, during the entire study period.
- •13. Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide
- •Vaccination with a live or live attenuated vaccine within 15 days prior to inclusion
- •History of cancer within the previous 5 years, except non-metastatic squamous cell and basal cell carcinoma of the skin.
- •16. Personal history of venous thromboembolic disease.
研究组 & 干预措施
Patient treated with baricitinib
Experimental
Patient treated with baricitinib at a dose of 4 mg per day, taken orally in the morning, with one tablet per day for 6 months.
干预措施: Baricitinib 4 MG (Drug)
结局指标
主要结局
Number of patients with complete remission
时间窗: 6 months
次要结局
- Number of patients with complete remission(3 months)
- Number of serious events(6 months)
- Number of patients with complete remission(1 month)
研究者
研究点 (1)
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