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

Terminated

• Conditions: Plaque Psoriasis

• Registration Number: NCT00402818
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-22
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 294

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.

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Exclusion Criteria

• Any contra-indication to Raptiva® according to the Canadian Product Monograph.
• Any simultaneous participation in another clinical evaluation trial for psoriasis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All serious and unexpected AEs	During the course of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Information - Canada; 🇨🇦 Mississauga, Ontario, Canada