Clinical trial NCT00402818: RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization
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®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Plaque Psoriasis
Keywords: Moderate to severe plaque psoriasis
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consenting 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. Subjects will be enrolled from the Raptiva®-treated clinical patient pool at the participating Canadian investigator site.

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.


Eligibility criteria: 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

Primary outcomes:
measure: All serious and unexpected AEs
timeFrame: During the course of the study
Secondary outcomes:
measure: Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI)
timeFrame: During the course of the study, there are no pre-defined scheduled visits
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Medical Information - Canada
state: Ontario
Study officials:
affiliation: EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Horia Ijacu, MD
role: STUDY_DIRECTOR
References: