RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and T... | NCT00402818

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

NCT00402818

Sponsor

Merck KGaA, Darmstadt, Germany

Status

Terminated

Last Update Posted

Aug 29, 2014Estimated

Enrollment

294Actual

Phase

Not provided

Conditions

Plaque Psoriasis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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®

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Nov 20, 2006

First Submission Date that Met QC Criteria

Nov 21, 2006

First Posted Date

Nov 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2014

Last Update Posted Date

Aug 29, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

294Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All serious and unexpected AEs		During the course of the study

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Horia Ijacu, MD	EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Information - Canada		Mississauga	Ontario		Canada