Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04885920
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2021-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Persisting to Treatment With Vedolizumab IV Compared to Participants With Treatment Change at 12 Months', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Time to any Treatment Change', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Number of Participants With Reason for Treatment Change', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Number of Participants With Change in Vedolizumab Dosing Frequency', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Number of Participants Who Discontinued the Vedolizumab Treatment', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Number of Participants Who Changed to Another Treatment', 'timeFrame': 'Baseline up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Inflammatory Bowel Diseases', 'Crohns Disease', 'Colitis, Ulcerative']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/60a2b6c1ef0b71001e743cb7', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': "Inflammatory bowel disease consists of either ulcerative colitis (UC) or Crohn's disease (CD).\n\nThe main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include the administration choices which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).\n\nTreatment will be determined by the study doctor according to routine clinical practice.", 'detailedDescription': 'This is a non-interventional, prospective study of participants with IBD who initiated or who are currently ongoing induction or maintenance with vedolizumab in the real world setting.\n\nThe study will enroll approximately 120 participants. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:\n\n* Participants with IBD\n\nThis multi-center study will be conducted in Croatia and Slovenia having specialized gastroenterology centers. The overall duration of the study will be at least 26 months. Data will be collected at baseline, at 3 months (+/- 1 month) after induction, and every 6 months (+/- 1 month) after that, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with moderately to severely active UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.\n\nExclusion Criteria:\n\n1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.\n2. Current or planned participation in an interventional clinical trial for CD or UC.\n3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.'}, 'identificationModule': {'nctId': 'NCT04885920', 'briefTitle': 'A Study on Administration Choices of Vedolizumab and Outcomes for Adults With Inflammatory Bowel Disease (IBD) (VARIETY - CROATIA AND SLOVENIA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes', 'orgStudyIdInfo': {'id': 'Vedolizumab-4036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants With IBD', 'description': 'Participants diagnosed with moderately to severely active IBD (UC or CD) who initiated or are currently ongoing vedolizumab IV induction treatment in accordance with the current Summary of Product Characteristics (SmPC) or receiving vedolizumab ongoing or maintenance IV treatment with the option to switch to vedolizumab SC treatment, will be observed prospectively for at least 12 months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Osijek', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Osijek (University medical centre Osijek)', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Rijeka (University medical centre Rijeka)', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Split (University medical centre Split)', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Sestre milosrdnice (University medical centre Sestre milosrdnice)', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Zagreb (University medical centre Zagreb)', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '3000', 'city': 'Celje', 'country': 'Slovenia', 'facility': 'Splosna bolnisnica Celje (General hospital Celje)', 'geoPoint': {'lat': 46.23092, 'lon': 15.26044}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Univerzitetni klinicni center Ljubljana (University medical Centre Ljubljana)', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '2000', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'Univerzitetni klinicni center Maribor (University medical centre Maribor)', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}