Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-27 @ 4:30 AM
Study NCT ID:
NCT06691061
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in 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': 'C543529', 'term': 'vedolizumab'}, {'id': 'D000075242', 'term': 'Janus Kinase Inhibitors'}], 'ancestors': [{'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and endoscopic effectiveness of the three treatments', 'timeFrame': '12 months', 'description': 'Rates of steroid-free clinical remission and endoscopic remission'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis (Disorder)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ulcerative colitis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;\n* Age ≥ 18 years-old;\n* Capability of expressing informed consent;\n* Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;\n* Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;\n* Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);\n* No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;\n* At least 1 follow-up visit after baseline\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;\n* Age \\< 18 years-old;\n* Incapability of expressing informed consent;\n* Acute severe UC requiring hospitalization at baseline;\n* No previous exposure to anti-TNFα therapies;\n* Previous treatment with target therapies other than anti-TNF-α for UC before baseline;\n* Ustekinumab or JAK inhibitors induction with a non-standard posology for UC."}, 'identificationModule': {'nctId': 'NCT06691061', 'briefTitle': 'The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Clinical and Research Center'}, 'officialTitle': 'Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance', 'orgStudyIdInfo': {'id': 'IBD-001-2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vedolizumab', 'type': 'DRUG', 'description': 'UC patients treated with vedolizumab'}, {'name': 'Ustekinumab - Standard Dosage', 'type': 'DRUG', 'description': 'UC patients treated with ustekinumab'}, {'name': 'JAK Inhibitor', 'type': 'DRUG', 'description': 'UC patients treated with JAK inhibitors'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Mialn', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Armuzzi', 'role': 'CONTACT', 'email': 'alearmuzzi@yahoo.com', 'phone': '0630159357'}], 'facility': 'Humanitas Research Hospital IRCSS'}], 'centralContacts': [{'name': 'Alessandro Armuzzi', 'role': 'CONTACT', 'email': 'alessandro.armuzzi@hunimed.eu', 'phone': '+39 02 8224 5555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Clinical and Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alessandro Armuzzi', 'investigatorAffiliation': 'Humanitas Clinical and Research Center'}}}}