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

Plaque Psoriasis Clinical Trial

— RESTORE  

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®

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00402818
• Other study ID #: 26768
• Status: Terminated
• Phase: Phase 4
• First received: November 20, 2006
• Last updated: August 28, 2014
• Start date: May 2006
• Est. completion date: July 2009

Study information

• Verified date: August 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 294
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Locations

Country	Name	City	State
Canada	Medical Information - Canada	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All serious and unexpected AEs		During the course of the study	Yes
Secondary	Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)		During the course of the study, there are no pre-defined scheduled visits	No