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

NCT00402818 | Terminated

• 1 other identifier: 26768
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

Moderate to severe plaque psoriasis

Outcome Measures

Primary Outcomes (1)

• All serious and unexpected AEs

  During the course of the study

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Medical Information - Canada

Mississauga, Ontario, Canada

Location

Study Officials

• Horia Ijacu, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

CA (1)