Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04743518
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059168', 'term': 'Carotid Intima-Media Thickness'}], 'ancestors': [{'id': 'D000092262', 'term': 'Ultrasonography, Carotid Arteries'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'variation of carotid intima media thickness (CIMT) between the 3 patient groups', 'timeFrame': 'at the end of month 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulcerative colitis', 'cardiovascular risk', 'CIMT'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ulcerative colitis evolving for at least 6 months,\n* Patient older than 18 years,\n* Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period,\n* Patients with a cardiovascular event such as myocardial infarction and stroke,\n* Diabetic patient,\n* Pregnant women,\n* Minor\n* people unable to give their consent to participate'}, 'identificationModule': {'nctId': 'NCT04743518', 'acronym': 'VASC-UC', 'briefTitle': 'Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'PI2020_843_0114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'anti-TNF', 'interventionNames': ['Other: Aortic pulse wave velocity', 'Other: carotid intima media thickness (CIMT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vedolizumab', 'interventionNames': ['Other: Aortic pulse wave velocity', 'Other: carotid intima media thickness (CIMT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tofacitinib', 'interventionNames': ['Other: Aortic pulse wave velocity', 'Other: carotid intima media thickness (CIMT)']}], 'interventions': [{'name': 'Aortic pulse wave velocity', 'type': 'OTHER', 'description': 'Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness', 'armGroupLabels': ['anti-TNF', 'tofacitinib', 'vedolizumab']}, {'name': 'carotid intima media thickness (CIMT)', 'type': 'OTHER', 'description': 'carotid intima media thickness (CIMT)', 'armGroupLabels': ['anti-TNF', 'tofacitinib', 'vedolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathurin Fumery, Pr', 'role': 'CONTACT', 'email': 'Fumery.mathurin@chu-amiens.fr', 'phone': '03 22 08 88 51'}, {'name': 'Marie-Antoinette Sevestre, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Mathurin Fumery, Pr', 'role': 'CONTACT', 'email': 'Fumery.mathurin@chu-amiens.fr', 'phone': '03 22 08 88 51'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}