Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-30 @ 2:30 AM
Study NCT ID:
NCT03964168
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the most common reason for discontinuation', 'timeFrame': '5 years', 'description': 'Tally number of patients who discontinued due to adverse events, insurance issues or category other.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider.', 'detailedDescription': 'Retrospective chart review and patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider. This research intends to improve the continuity of care by determining why patients stop therapy and what can be done to improve their experience with the provider, pharmaceutical companies and specialty pharmacies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female adults ≥ 18 years of age.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults ≥ 18 years of age.\n* Was receiving first or second biologic therapy\n* Has not had a follow up with treating physician in ≥ 9 months\n\nExclusion Criteria:\n\n* Actively receiving biologic therapy\n\n * Was not receiving first or second biologic therapy'}, 'identificationModule': {'nctId': 'NCT03964168', 'briefTitle': 'An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers', 'organization': {'class': 'OTHER', 'fullName': 'Psoriasis Treatment Center of Central New Jersey'}, 'officialTitle': 'An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers', 'orgStudyIdInfo': {'id': 'PTC05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biologic Therapy', 'description': "Patient's who received and discontinued a biologic therapy", 'interventionNames': ['Drug: Biologic Agent']}], 'interventions': [{'name': 'Biologic Agent', 'type': 'DRUG', 'description': 'Patients who discontinued a bioloic agent', 'armGroupLabels': ['Biologic Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Psoriasis Treatment Center of Central New Jersey', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psoriasis Treatment Center of Central New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}