NCT00050661已完成1 期
Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody/ Placebo to Prevent Relapse of Psoriasis Vulgaris Following NBUVB Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- time to disease relapse
研究概览
简要总结
This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.
详细描述
The first part of the study involves NB-UVB light treatment, a well-established treatment to treat psoriasis. In the second part, we are testing a drug known as Humanized CD25 Monoclonal Antibody (anti-TAC) or placebo to prevent disease relapse. Anti-TAC is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.
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
- 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
- 未提供
排除标准
- •Positive serology for HIV, Hepatitis B, or Hepatitis C.
- •Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
- •Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
- •Active infection or persistent fever of unknown origin.
- •Major concurrent illness, which could worsen following treatment with anti-TAC.
研究组 & 干预措施
Narrow Band Ultraviolet B
Active Comparator
312nm
干预措施: NB-UVB (Device)
anti-TAC or placebo
Experimental
干预措施: Daclizumab (Drug)
结局指标
主要结局
time to disease relapse
时间窗: After a course of NB-UVB treatment
次要结局
- Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.(before and after NB-UVB treatment)
研究者
研究点 (2)
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