Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04915105
Status:
UNKNOWN
Last Update Posted:
2021-06-07
First Post:
2021-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personal Precise Treatment on Psoriasis and Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'C563250', 'term': 'Salivary Gland Adenoma, Pleomorphic'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PASI score', 'timeFrame': '2 weeks to 3 months', 'description': 'Psoriasis skin condition and severity'}, {'measure': 'swelling joint count and tenderness joint count', 'timeFrame': '2 weeks to 3 months', 'description': 'PSA severity'}], 'secondaryOutcomes': [{'measure': 'CRP', 'timeFrame': '3-6 months', 'description': 'blood test'}, {'measure': 'DLQI', 'timeFrame': '6 months', 'description': 'paper to investigate patient life quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSO, PSA, SLE, PBMC'], 'conditions': ['Dermatologic Disease']}, 'descriptionModule': {'briefSummary': 'Part of psoriasis and psoriatic arthritis patients treated with biologics and met primary failure. Therefore, we are going to create a cell based platform to evaluate the treatment effects of different biologics on psoriasis and psoriatic arthritis patients before prescribed by physicians', 'detailedDescription': "PBMCs isolated from psoriasis and psoriatic arthritis and incubated with Group A streptococcus and different biologics for 24 hours. Cytokines expression in the culture supernatants will be measured and the data can be reference for physician's prescription."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Healthy control without underline disease such as psoriasis and psoriatic arthritis. 2. Psoriasis been diagnosed for over six months and PASI \\>10. 3.Psoriatic arthritis been diagnosed for over six months and \\>1 swallow and tender joints\n\nExclusion Criteria:\n\n* nil'}, 'identificationModule': {'nctId': 'NCT04915105', 'briefTitle': 'Personal Precise Treatment on Psoriasis and Psoriatic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Personal Precise Treatment on Psoriasis and Psoriatic Arthritis and Investigate the Mechanisms of Biological Agents Induced Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'CE20043B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prescreen on psoriasis and psoriatic arthritis treatment', 'description': 'Prescreen markers from individual PBMCs and choose proper biologics before starting treatment on psoriasis and psoriatic arthritis patients.', 'interventionNames': ['Diagnostic Test: Markers data from PBMCs']}], 'interventions': [{'name': 'Markers data from PBMCs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.', 'armGroupLabels': ['Prescreen on psoriasis and psoriatic arthritis treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chung-Yang Yen, MDPhD', 'role': 'CONTACT', 'email': 'vernayen@yahoo.com.tw', 'phone': '886423592525', 'phoneExt': '5304'}], 'overallOfficials': [{'name': 'Chung-Yang Yen, MDPhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Attending Physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}