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

This study has been terminated.
(The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU)
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00402818
First received: November 20, 2006
Last updated: December 15, 2009
Last verified: December 2009
  Purpose

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.

Condition Phase
Plaque Psoriasis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • All serious and unexpected AEs [ Time Frame: During the course of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI) [ Time Frame: During the course of the study, there are no pre-defined scheduled visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: May 2006
Study Completion Date: November 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402818

Locations
Canada, Ontario
Medical Information - Canada
Mississauga, Ontario, Canada
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Horia Ijacu EMD Serono
  More Information

No publications provided

Responsible Party: Horia Ijacu, MD, Medical Director, Marketed Products, EMD Serono Canada Inc.
ClinicalTrials.gov Identifier: NCT00402818     History of Changes
Other Study ID Numbers: 26768
Study First Received: November 20, 2006
Last Updated: December 15, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Merck KGaA:
Moderate to severe plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014