跳至主要内容
临床试验/NCT00050648
NCT00050648已完成1 期

Use of Humanized CD25 (Anti-TAC) Monoclonal Antibody and Cyclosporine for the Treatment of Active Psoriasis.

Rockefeller University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 1997年10月最近更新:
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
20
试验地点
2
主要终点
clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination

研究概览

简要总结

This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.

详细描述

The purpose is to study the safety and effectiveness of a new drug called "anti-TAC" (anti-CD25) Monoclonal Antibody used together with low dose Cyclosporine in the treatment of psoriasis. While the exact cause of psoriasis is unknown, it is believed to involve white blood cells called lymphocytes, which become activated in the skin. It is believed that these activated cells are responsible for the changes you see as the rash of psoriasis. Anti-TAC (anti-CD25) Monoclonal Antibody is designed to block the activation of these lymphocytes. Because the anti-TAC (anti-CD25) Monoclonal Antibody targets the specific cells involved in the symptoms of psoriasis, this new drug may be a better way to treat psoriasis. The second drug, Cyclosporine, is an FDA-approved drug in the treatment of psoriasis. There is evidence in the laboratory that Cyclosporine and anti-TAC, used together, will have an additive effect. An additional benefit of this study is that we are using a lower dose of cyclosporine than is usually given when it is used alone because it is being used together with anti-TAC. This should reduce the side effects usually seen with higher doses of Cyclosporine when it is used as a single drug for psoriasis. The purpose of this study is to test the safety and effectiveness of anti-TAC (Monoclonal Antibody and low dose cyclosporine in patients with active, moderate to severe psoriasis vulgaris. We also hope to gain more information on how anti-TAC works in the body

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

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. 5.) Major concurrent illness, which could worsen following treatment with DaclizumabTM.
  • Any history of an un-treated neoplasm

研究组 & 干预措施

cyclosporine

Active Comparator

oral medication 2mg/kg/day orally from Day 0 until Day 90

干预措施: Cyclosporine (Drug)

anti-TAC

Active Comparator

1mg/kg/dose medication every other week on the odd week (week 1-13)

干预措施: Daclizumab (Drug)

Cyclosporine and anti-TAC

Experimental

DaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day)

干预措施: cyclosporine and Daclizumab (Drug)

结局指标

主要结局

clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination

时间窗: day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验