NCT00646425终止2 期
Randomized, Double-Masked, Placebo-controlled Evaluation of the Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis Who Undergo Tapering of Concomitant Immunosuppressive Medications
Cerimon Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications
研究概览
简要总结
The objective of this trial is to assess if treatment with basiliximab allows subjects to taper off other immunosuppressive drug regimens without causing an increase in their uveitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of noninfectious intermediate, posterior or panuveitis of at least 3 months duration
- •Treatment with greater than or equal to 20 mg/day of Prednisone at baseline or immunosuppressive drug score of greater than or equal to 5 at baseline
- •BCVA by ETDRS protocol better than or equal to 20/200
- •Intraocular pressure of 24 mmHg or less
- •Anterior chamber cells and vitreous haze of less than or equal to 1
- •Male or females, aged 12 or greater, body weight of 40 kg or greater
排除标准
- •Prior treatment with Retisert
- •Primary diagnosis of anterior uveitis, uveitis of infectious etiology or Behcet's disease
- •Pregnancy or breast-feeding
- •Increase in systemic immunosuppressive treatment regimen within 6 weeks before baseline
研究组 & 干预措施
1
Experimental
Basiliximab
干预措施: Basiliximab (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To prevent an increase in disease activity as measured by anterior cell count, vitreal haze and visual acuity while subjects with stable noninfectious uveitis undergo tapering of concomitant immunosuppressive medications
时间窗: The primary outcome will be assessed at Week 16
次要结局
- Secondary objectives are to assess changes in visual acuity, retinal thickness, corticosteroid dose, and immunosuppressive drug score. Basiliximab pharmacokinetics and immunogenicity will also be assessed(These measures will be assessed at Week 16)
研究者
研究点 (6)
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