跳至主要内容
临床试验/NCT00195507
NCT00195507已完成4 期

A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis

Wyeth is now a wholly owned subsidiary of Pfizer127 个研究点 分布在 7 个国家目标入组 720 人开始时间: 2004年12月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
720
试验地点
127
主要终点
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks

研究概览

简要总结

This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.

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

  • Stable, active plaque psoriasis
  • Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate

排除标准

  • Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
  • Systemic psoriasis therapy within 28 days prior

结局指标

主要结局

Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks

时间窗: 54 weeks

Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).

次要结局

  • Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline(54 weeks)
  • Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"(54 weeks)
  • Number of Patients With Survey Response of "Somewhat Satisfied" or Better(54 weeks)

研究者

发起方
Wyeth is now a wholly owned subsidiary of Pfizer
申办方类型
Industry

研究点 (127)

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