Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT00402818
Status:
TERMINATED
Last Update Posted:
2014-08-29
First Post:
2006-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization
Sponsor:
Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
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®
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: