Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT04191395
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2019-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution and Treatments of Chronic Inflammatory Systemic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of a second inflammatory disease', 'timeFrame': 'through study completion (up to 10 years)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Ulcerative Colitis', 'Crohn Disease', 'Arthritis, Rheumatoid', 'Spondyloarthritis', 'Psoriatic Arthritis', 'Psoriasis', "Verneuil's Disease"]}, 'descriptionModule': {'briefSummary': "Patients with chronic inflammatory diseases (CID) followed in gastroenterology, dermatology and rheumatology have physiopathological, epidemiological and therapeutic focal points. The pathologies concerned are inflammatory bowel diseases (IBD - Crohn's disease \\[MC\\] and ulcerative colitis \\[RCH\\]), chronic inflammatory skin diseases (psoriasis or Verneuil's disease) and chronic inflammatory rheumatic diseases (rheumatoid arthritis \\[RA\\] and spondyloarthritis \\[SpA\\] including psoriatic arthritis \\[PsA\\]). Presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. An association of extra-articular manifestations is observed in 10 to 30% of patients with SpA, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with IBD. No common database for chronic systemic inflammatory diseases currently exists in France."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Inflammatory Bowel Disease, Chronic Inflammatory Skin Diseases or Chronic inflammatory rheumatic disease', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients treated for IBD (MC, UC or indeterminate colitis) in the gastroenterology department of Besançon University Hospital\n* Subject meeting the clinical, morphological and histological diagnostic criteria for MC, UC or indeterminate colitis or\n* Patients treated for chronic inflammatory rheumatism (RA, SpA, PsA) in the rheumatology department of the University Hospital of Besançon Subject meeting the ACR 2010 classification criteria of RA or modified New York criteria of Ankylosing spondylitis or ASAS criteria of axial or peripheral SpA or CASPAR criteria of PsA or\n* Patients treated for chronic inflammatory skin disease (Psoriasis, Verneuil's disease) in the dermatology department of the University Hospital of Besançon\n\nExclusion Criteria:\n\n* Opposition of the patient\n* Patients in emergency situation, persons deprived of their liberty, protected minors or adults."}, 'identificationModule': {'nctId': 'NCT04191395', 'acronym': 'MISTIC', 'briefTitle': 'Evolution and Treatments of Chronic Inflammatory Systemic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Evolution and Treatments of Chronic Inflammatory Systemic Diseases: Implementation of a Hospital Cohort in the Gastroenterology, Dermatology and Rheumatology Departments of the University Hospital of Besançon', 'orgStudyIdInfo': {'id': 'P/2019/433'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inflammatory bowel disease'}, {'label': 'Chronic inflammatory rheumatic disease'}, {'label': 'Chronic inflammatory skin diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charline Vauchy, PhD', 'role': 'CONTACT', 'email': 'cvauchy@chu-besancon.fr'}, {'name': 'Clément Prati, Prof.', 'role': 'CONTACT'}, {'name': 'Lucine Vuitton, Prof.', 'role': 'CONTACT'}, {'name': 'François Aubin, Prof.', 'role': 'CONTACT'}], 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Charline Vauchy, PhD', 'role': 'CONTACT', 'email': 'cvauchy@chu-besancon.fr', 'phone': '0381218875'}, {'name': 'Stéphanie François', 'role': 'CONTACT', 'email': 'sfrancois@chu-besançon.fr'}], 'overallOfficials': [{'name': 'Clément Prati, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Besançon'}, {'name': 'Lucine Vuitton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}