Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT00402818
Status:
TERMINATED
Last Update Posted:
2014-08-29
First Post:
2006-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was terminated after the EMEA recommended to suspend the marketing authorisation of Raptiva in the EU', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2006-11-20', 'studyFirstSubmitQcDate': '2006-11-21', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All serious and unexpected AEs', 'timeFrame': 'During the course of the study'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['Moderate to severe plaque psoriasis'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': '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.\n\nObjectives:\n\n* To document and quantify the incidences of adverse events in this patient population\n* To explore the association of psoriasis treatments with changes in patient outcomes, quality of life, and treatment compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years old.\n* Have a clinical diagnosis of moderate to severe chronic plaque psoriasis and be a candidate for treatment with Raptiva®.\n* Are being treated or are initiating treatment with Raptiva® at time of study enrolment in accordance with the Canadian Product Monograph indication and recommendations.\n* Be able to provide written informed consent.\n* Agreement to participate in the study, and to disclose any medical events to the Investigator.\n* The subject must be willing and able to comply with the protocol requirements for the duration of the study.\n\nExclusion Criteria:\n\n* Any contra-indication to Raptiva® according to the Canadian Product Monograph.\n* Any simultaneous participation in another clinical evaluation trial for psoriasis'}, 'identificationModule': {'nctId': 'NCT00402818', 'acronym': 'RESTORE', 'briefTitle': 'RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': '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®', 'orgStudyIdInfo': {'id': '26768'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medical Information - Canada', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'overallOfficials': [{'name': 'Horia Ijacu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMD Canada Inc., an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}