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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00402818

Acronym

RESTORE

Enrollment

294

Registered

2006-11-22

Start date

2006-05-31

Completion date

2009-07-31

Last updated

2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

Moderate to severe plaque psoriasis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
All serious and unexpected AEs	During the course of the study

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results