NCT00889421终止1 期
An Open-label Trial to Assess the Efficacy and Safety of Apremilast in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with vision-threatening autoimmune uveitis
- •failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
排除标准
- •serious concomitant illness that could interfere with the subject's participation
- •previous or current use of an alkylating agent
- •use of CYP3A4 inhibitors during the trial
- •TNF blocker use within the 8 weeks prior to enrollment
研究组 & 干预措施
Treatment
Experimental
Patients receiving apremilast.
干预措施: Apremilast (Drug)
结局指标
主要结局
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
时间窗: 6 months
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
时间窗: 6 months
Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)
时间窗: 6 months
Reduction in Cystoid Macular Edema
时间窗: 6 months
次要结局
- Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment(7 months)
研究者
Eric B. Suhler
Principal Investigator
Oregon Health and Science University
研究点 (1)
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