Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-28 @ 11:10 AM
Study NCT ID:
NCT04964661
Status:
UNKNOWN
Last Update Posted:
2021-07-26
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of MRI Sacro-Iliac (SI) Joint Anomalies in Women With Spondyloarthritis (SpA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 530}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of MRI inflammatory of the sacroiliac joints', 'timeFrame': 'day 1', 'description': 'MRI inflammatory of the sacroiliac joints in the population of women affected by SpA'}], 'secondaryOutcomes': [{'measure': 'Rate of structural lesions of the sacroiliac joints', 'timeFrame': 'day 1', 'description': 'structural lesions of the sacroiliac joints in the population of women affected by SpA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diagnostic Imaging', 'Magnetic Resonance Imaging', 'Sacroiliac Joint anomalies'], 'conditions': ['Spondylarthritis']}, 'descriptionModule': {'briefSummary': 'Retrospective study comparing the incidence of inflammatory and structural lesions seen on MRI of the sacro-iliac (SI) joints in a population of women affected by spondyloarthritis (SpA) and control women population (MISIA study NCT02956824).\n\nA previous study (MISIA) demonstrate SpA may be misdiagnosed on MRI in postpartum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics SpA.\n\nThe primary objective of this study is to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints between SpA and control women, and determine differentiation criteria in SpA women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 18 to 50 years old Affected by spondyloarthritis Performed sacroiliac joint MRI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Women aged 18 to 50 years old\n* SpA diagnosed\n* Pelvis MRI performed\n\nExclusion criteria:\n\n\\- Pelvis MRI unavailable'}, 'identificationModule': {'nctId': 'NCT04964661', 'acronym': 'MISIA 2', 'briefTitle': 'Incidence of MRI Sacro-Iliac (SI) Joint Anomalies in Women With Spondyloarthritis (SpA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Incidence of Sacro-iliac (SI) Joint Anomalies on MRI: Differentiation Criteria in Women With Spondyloarthritis (SpA', 'orgStudyIdInfo': {'id': 'RECHMPL20_0612'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SpA women MRI', 'description': 'Women affected by spondyloarthritis and performed a sacroiliac MRI', 'interventionNames': ['Other: Medical Imaging']}], 'interventions': [{'name': 'Medical Imaging', 'type': 'OTHER', 'description': 'MRI imaging', 'armGroupLabels': ['SpA women MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Catherine CYTEVAL, MD.PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}