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®
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
- 否
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
研究点 (1)
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