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

Merck KGaA (EMD Serono)

Status: Terminated

Conditions: Plaque Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT00402818

26768

Details and patient eligibility

About

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.

Enrollment: 294 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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