NCT00525902已完成2 期
An Open-label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Cumulative Endpoint
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Adalimumab in 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 (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects.
排除标准
- •Serious concomitant illness that could interfere with the subject's participation in the trial.
- •Previous or current use of cyclophosphamide.
- •Unable or unwilling to undergo multiple injections.
研究组 & 干预措施
Adalimumab
Experimental
干预措施: Adalimumab (Drug)
结局指标
主要结局
Cumulative Endpoint
时间窗: 50 Weeks
Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.
次要结局
未报告次要终点
研究者
Eric B. Suhler
Associate Professor
Oregon Health and Science University
研究点 (1)
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