RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization
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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.
| 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 |
- All serious and unexpected AEs [ Time Frame: During the course of the study ] [ Designated as safety issue: Yes ]
- 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 |
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.
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 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 May 22, 2013