RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization

Merck KGaA, Darmstadt, Germany294 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

294

Conditions

Plaque Psoriasis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Any contra-indication to Raptiva® according to the Canadian Product Monograph. * Any simultaneous participation in another clinical evaluation trial for psoriasis

Outcomes

Primary Outcomes

All serious and unexpected AEs

Time frame: During the course of the study

Secondary Outcomes

Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)

Time frame: During the course of the study, there are no pre-defined scheduled visits