Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT00184366
Status:
TERMINATED
Last Update Posted:
2012-01-19
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C472181', 'term': 'efalizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'whyStopped': 'efalizumab was withdrawn from market; full 2 years follow-up only 14 patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response PASI 75', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Dermatology Life Quality index (DLQI)', 'timeFrame': '2 years'}, {'measure': 'Psoriasis disability Index (PDI)', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['drug therapy', 'efalizumab'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The main objectives of the project are:\n\n* To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)\n* To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.', 'detailedDescription': 'This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc.\n\nWe will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients of both genders, over the age of 18 years who have been suffering from moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current Norwegian guidelines.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe plaque psoriasis for more than six months\n* eligible for efalizumab treatment according to current Norwegian guidelines\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding patients\n* Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection.\n* Patients suffering from HIV, Hepatitis B or C, active tuberculosis, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year.\n* Patients with history of cancer in the preceding 5 years, including lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled.\n* Patients with impaired renal or hepatic function.'}, 'identificationModule': {'nctId': 'NCT00184366', 'briefTitle': 'Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab', 'orgStudyIdInfo': {'id': 'ROCAC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'efalizumab', 'type': 'DRUG', 'description': 'efalizumab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Dep of dermatology, St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Morten Dalaker, univ lekt II', 'role': 'STUDY_CHAIR', 'affiliation': 'St Olavs hospital, NTNU, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}