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

NCT ID: NCT00402818

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horia Ijacu, MD

Role: STUDY_DIRECTOR

EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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Medical Information - Canada

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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26768

Identifier Type: -

Identifier Source: org_study_id

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