Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02503059
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etanercept Survival in Elderly Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary ineffectiveness in patients with etanercept treatment', 'timeFrame': '24 weeks', 'description': 'Number of participants not achieve PASI 50 response at 12 weeks'}, {'measure': 'Secondary ineffectiveness in patients with etanercept treatment', 'timeFrame': '24 weeks (duration of treatment with etanercept)', 'description': 'Number of participants with Poor adherence to treatment with etanercept",'}, {'measure': 'Ineffectiveness of treatment in localized lesions in patients with etanercept treatment', 'timeFrame': '24 weeks(duration of treatment with etanercept)', 'description': 'Despite having achieved a good response PASI no improvement in critical injuries'}, {'measure': 'primary ineffectiveness in patients with etanercept treatment', 'timeFrame': '24 weeks', 'description': 'Number of participants not achieve PASI 75 response at 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events during treatment with etanercept', 'timeFrame': '24 weeks'}, {'measure': 'Number of participants with disease remission', 'timeFrame': '24 weeks'}, {'measure': 'number of participants with Poor adherence to treatment with etanercept', 'timeFrame': '24 weeks'}, {'measure': 'number of participants with Conditions requiring hospitalization and / or surgery', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in moderate / severe plaque and the reasons that led to the abandonment. Besides factors that might have had a positive or negative influence on adherence to treatment and analysis of efficacy (PASI 75) and safety will be identified.\n\nAll variables were collected through retrospective review of medical records of patients dermatology unit are made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 60 who received etanercept for the treatment of moderate / severe psoriasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate / severe psoriasis (with / without psoriatic arthritis,PAs) defined by: PASI(Psoriasis Area and Severity Index)\\> 10 and / or BSA(Body Surface Area)\\> 10% and / or DLQI(Dermatology Life Quality Index)\\> 10\n* PASI\\> 10 and / or BSA(Body Surface Area)\\> 10% and / or DLQI(Dermatology Life Quality Index)\\> 10\n* Over 60 years of age at the start of treatment\n* Receiving etanercept at any time\n* Available history in the Dermatology\n\nExclusion Criteria:\n\n* Patients with insufficient clinical data in the medical record'}, 'identificationModule': {'nctId': 'NCT02503059', 'briefTitle': 'Etanercept Survival in Elderly Population', 'organization': {'class': 'OTHER', 'fullName': 'Andalusian Network for Design and Translation of Advanced Therapies'}, 'officialTitle': 'Etanercept Survival in Elderly Population', 'orgStudyIdInfo': {'id': 'FPA-ETA-2014-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'facility': 'H.U. Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Jaén', 'state': 'Jaén', 'country': 'Spain', 'facility': 'Hospital de Andújar', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital la Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'H.U. Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Enrique Herrera Ceballos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'H.U. Virgen de la Victoria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza Progreso y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}