NCT00402818

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

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®

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 294 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plaque Psoriasis

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-11-22
• Last updated: 2014-08-29

Locations

1 site across 1 country: Canada