Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-30 @ 4:31 PM
Study NCT ID:
NCT01673633
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2012-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacroiliitis in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D058566', 'term': 'Sacroiliitis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of sacroiliitis in systemic sclerosis', 'timeFrame': 'One year'}]}, 'conditionsModule': {'conditions': ['Systemic Sclerosis', 'Sacroiliitis', 'Inflammatory Back Pain']}, 'descriptionModule': {'briefSummary': 'One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular involvement. Mostly involved joints in SSc were reported as wrist, carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this joint in SSc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers\n\nExclusion Criteria:\n\n* Not giving informed consent'}, 'identificationModule': {'nctId': 'NCT01673633', 'briefTitle': 'Sacroiliitis in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'orgStudyIdInfo': {'id': 'Sacroiliitis in SSc'}, 'secondaryIdInfos': [{'id': '05/01/2012-4/21', 'type': 'OTHER', 'domain': '05/01/2012-4/21'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'SSc', 'description': 'Sacroiliitis'}, {'label': 'Rheumatoid arthritis', 'description': 'Sacroiliitis'}, {'label': 'Healthy controls', 'description': 'Sacroiliitis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internist and rheumatologist', 'investigatorFullName': 'Didem Arslan Tas', 'investigatorAffiliation': 'Cukurova University'}}}}