跳至主要内容
临床试验/NCT00402818
NCT00402818终止不适用

RESTORE (Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization Registry) Observational, Open-label, Multi-centre, Phase IV Study of Subcutaneously Administered Raptiva® (Efalizumab) in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Treatment With Raptiva®

Merck KGaA, Darmstadt, Germany1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
294
试验地点
1
主要终点
All serious and unexpected AEs

研究概览

简要总结

RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall duration of the study is approximately 4 years. Patients will be followed from the time of study enrolment to study/treatment termination; thus active follow-up period will vary across subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study.

Objectives:

  • To document and quantify the incidences of adverse events in this patient population
  • To explore the association of psoriasis treatments with changes in patient outcomes, quality of life, and treatment compliance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female ≥ 18 years old.
  • Have a clinical diagnosis of moderate to severe chronic plaque psoriasis and be a candidate for treatment with Raptiva®.
  • Are being treated or are initiating treatment with Raptiva® at time of study enrolment in accordance with the Canadian Product Monograph indication and recommendations.
  • Be able to provide written informed consent.
  • Agreement to participate in the study, and to disclose any medical events to the Investigator.
  • The subject must be willing and able to comply with the protocol requirements for the duration of the study.

排除标准

  • Any contra-indication to Raptiva® according to the Canadian Product Monograph.
  • Any simultaneous participation in another clinical evaluation trial for psoriasis

结局指标

主要结局

All serious and unexpected AEs

时间窗: During the course of the study

次要结局

  • Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)(During the course of the study, there are no pre-defined scheduled visits)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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