RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization (RESTORE)
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|ClinicalTrials.gov Identifier: NCT00402818|
Recruitment Status : Terminated (The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU)
First Posted : November 22, 2006
Last Update Posted : August 29, 2014
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.
|Condition or disease||Phase|
|Plaque Psoriasis||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||294 participants|
|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®|
|Study Start Date :||May 2006|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
- All serious and unexpected AEs [ Time Frame: During the course of the study ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402818
|Medical Information - Canada|
|Mississauga, Ontario, Canada|
|Study Director:||Horia Ijacu, MD||EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany|