Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04892602
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibromyalgia in Rheumatiod and Psoriatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-01-11', 'releaseDate': '2022-04-12'}], 'estimatedResultsFirstSubmitDate': '2022-04-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2021-05-16', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum vitamin D level', 'timeFrame': 'One year', 'description': 'Blood test to asses hypovitaminosis in these patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia, Secondary']}, 'descriptionModule': {'briefSummary': 'the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum Vitamin D level in those patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Those patient who diagnosed as rheumatiod arthritis and psoriatic arthritis..assess serum vitamin D level', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old\n\nExclusion Criteria:\n\n* any other autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT04892602', 'briefTitle': 'Fibromyalgia in Rheumatiod and Psoriatic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Fibromyalgia in Rheumatiod and Psoriatic Arthritis Patients:Relationshipwith Disease Activity and Serum Vitamin Dlevel', 'orgStudyIdInfo': {'id': 'Soh-Med-21-05-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatiod arthritis patients', 'interventionNames': ['Diagnostic Test: Serum vitaminDlevel']}, {'label': 'Psoaritic arthritis', 'interventionNames': ['Diagnostic Test: Serum vitaminDlevel']}, {'label': 'Control group', 'interventionNames': ['Diagnostic Test: Serum vitaminDlevel']}], 'interventions': [{'name': 'Serum vitaminDlevel', 'type': 'DIAGNOSTIC_TEST', 'description': 'Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level', 'armGroupLabels': ['Control group', 'Psoaritic arthritis', 'Rheumatiod arthritis patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Serum Vitamin Dlevel Disease activity indice'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alshimaa hamdy khalaf', 'investigatorFullName': 'Alshimaa Hamdey Khalaf', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-12', 'type': 'RELEASE'}, {'date': '2023-01-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alshimaa Hamdey Khalaf, Alshimaa hamdy khalaf, Sohag University'}}}}