Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-29 @ 11:32 AM
Study NCT ID:
NCT06077604
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2023-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a SpA flare-up', 'timeFrame': '6 to 24 months', 'description': 'The occurrence of a SpA flare-up measured by disease activity, defined according to the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and/or ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score - C reactive protein) scores (BASDAI score ≥4/10 and/or ASDAS-CRP score ≥2.1) according to ASAS group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Air pollution'], 'conditions': ['Spondyloarthritis, Axial']}, 'descriptionModule': {'briefSummary': 'The relationship between exposure to air pollution and spondyloarthritis (SpA) has been poorly studied. Based on data from the literature on other inflammatory pathologies such as rheumatoid arthritis, we hypothesize that there is a relationship between exposure to air pollution and the risk of presenting a flare-up in SpA patients following and living in Franche-Comté (France).\n\nPrimary objective:The potential relationship between exposure to air pollution (nitrogen dioxide, fine particles with a diameter of less than 10 or 2.5 microns and Ozone) and the onset of a spondyloarthritis flare-up will be explored in patients with this pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of Axial Spondyloarthritis, received in rheumatology consultation/hospitalization over the period 2019-2022 and living in Franche-Comté over the same period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Axial Spondyloarthritis (radiographic or non-radiographic) according to Assessment of SpondyloArthritis international Society (ASAS) criteria\n* Patient having received a consultation / hospitalization during the period 2019-2022\n* Patient enrolled in the MISTIC cohort\n* Having lived in Franche-Comté during the 2019-2022 period.\n\nExclusion Criteria:\n\n* Other chronic inflammatory rheumatism (rheumatoid arthritis according to ACR 2010 criteria or psoriatic arthritis according to ClASsification criteria for Psoriatic ARthritis criteria)\n* No inflammatory rheumatic disease'}, 'identificationModule': {'nctId': 'NCT06077604', 'acronym': 'SPAIR', 'briefTitle': 'Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment', 'orgStudyIdInfo': {'id': '2023/811'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a diagnosis of Axial Spondyloarthritis', 'description': 'Patients with a diagnosis of Axial Spondyloarthritis, received in rheumatology consultation/hospitalization over the period 2019-2022 and living in Franche-Comté over the same period', 'interventionNames': ['Other: Assessment of exposure to air pollution']}], 'interventions': [{'name': 'Assessment of exposure to air pollution', 'type': 'OTHER', 'description': 'For each patient, exposure to air pollution will be assessed over a period immediately prior to any flare-up and over four periods at a distance from the flare-up.', 'armGroupLabels': ['Patients with a diagnosis of Axial Spondyloarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'Besançon University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}