RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization (RESTORE)
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.
- 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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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®|
- All serious and unexpected AEs [ Time Frame: During the course of the study ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402818
|Medical Information - Canada|
|Mississauga, Ontario, Canada|
|Study Director:||Horia Ijacu, MD||EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany|