Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-13 @ 11:19 PM
Study NCT ID:
NCT07123350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
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'}], '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospitalization and ED visits related to IBD', 'timeFrame': '12 months before and after switch to SC', 'description': 'Determined based on visits documented in patient chart'}, {'measure': 'Adverse events reported after switching to SC', 'timeFrame': '12 months post switch to SC', 'description': 'Will only be assessed for patients filling with Vanderbilt Specialty Pharmacy'}, {'measure': 'Drug trough levels before and after switching to SC', 'timeFrame': '12 months before and after switching to SC', 'description': 'Vedolizumab trough levels'}], 'primaryOutcomes': [{'measure': 'Remission', 'timeFrame': 'baseline with IV dosing, and 3, 6, 9, 12 months after switching to SC', 'description': 'Remission will be defined if any of the following is met: 1) Clinical remission as written by provider in last office visit note, 2) Endoscopic remission as written by provider from last colonoscopy report, 3) Fecal calprotectin \\<250 μg/g, 4) CRP \\<5 mg/L (or below cut-off for normal range for the laboratory), 5) In CD, HBI \\< 4, or 6) In UC, SCCAI \\< 2.5'}], 'secondaryOutcomes': [{'measure': 'Dosing patterns of IV dose/frequency and SC dose/frequency', 'timeFrame': 'At baseline and up to 12 months after switching', 'description': 'standard dosing vs escalated dosing; includes any dose changes of the SC product within 12 months after switching from IV to SC'}, {'measure': 'SIBDQ score', 'timeFrame': 'Baseline and 12 months post switch to SC', 'description': "Short Inflammatory Bowel Disease Questionnaire: 10-item validated health-related quality of life tool that measures physical, social, and emotional status. It is designed to evaluate how the patient is feeling over the past two weeks. The 10 questions are given scores of 1 to 7 with an overall score of 10 to 70. The lower the score, the more severe the disease is impacting the patient's quality of life (QOL)."}, {'measure': 'Persistence to SC formulation', 'timeFrame': 'Up to 12 months after switching', 'description': 'Measured by time to discontinuation; will include reason for discontinuation if SC stopped'}, {'measure': 'Adverse events to vedolizumab SC', 'timeFrame': 'Up to 12 months after switching', 'description': 'Adverse events to vedolizumab SC that required change back to IV'}, {'measure': 'Adherence', 'timeFrame': '12 months post switch to SC', 'description': 'Measured by PDC'}, {'measure': 'Patient-reported missed doses', 'timeFrame': '12 months post switch to SC', 'description': 'For patients filling with Vanderbilt Specialty Pharmacy only; will include reasons for patient-reported missed doses'}, {'measure': 'Maintenance steroid use for IBD', 'timeFrame': '12 months post switch to SC', 'description': 'Will determine if maintenance steroids were used for maintenance post switch to SC (yes/no)'}, {'measure': 'Number of steroid prescriptions for flares', 'timeFrame': '12 months before and after switch', 'description': 'Based on prescription history in patient chart'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Health-system Specialty Pharmacy', 'Vedolizumab'], 'conditions': ['Inflammatory Bowel Disease (IBD)', 'Crohn&Amp;#39;s Disease (CD)', 'Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': 'The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration.\n\nPatients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and December 31, 2024, as part of normal patient care, will be retrospectively reviewed and analyzed.', 'detailedDescription': "Vedolizumab intravenous (IV) infusions have been a first-line treatment option for patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) for over ten years. Recently, vedolizumab has been approved by the Food and Drug Administration for subcutaneous (SC) administration in the United States, offering patients a more convenient treatment option with medication administration at home. Evidence, largely from European countries where the SC formulation of vedolizumab has been available since 2020, shows a durable and potentially improved clinical response when switching to the SC formulation. A high SC treatment persistence has been found, mainly above 80%. Additionally, many patients accept the transition to SC vedolizumab as a safe and feasible treatment option and noting that the shorter treatment duration was specifically advantageous.\n\nCurrent evidence is limited by the minimal amount of data on patients transitioning from IV to SC vedolizumab. For treatment with vedolizumab IV to SC, large scale, real-life studies with long term follow-up are necessary. More research is needed to further evaluate predictors for a relapse when transitioning from IV to SC therapy that have been seen in previous studies, including older age, escalated IV dosing, fecal calprotectin \\>250 microgram/gram at baseline, and CRP \\> 2g/L at baseline. We must also evaluate patient clinical outcomes after switching from IV to SC vedolizumab or infliximab and potential predictors for a positive response. These results will drive clinical decisions and further understanding of treatment expectations.\n\nThere is also a large gap in available information on standard and escalated dosing patterns before and after switching from IV to SC vedolizumab. Minimal research has evaluated whether or not patients on escalated IV dosing maintain escalated dosing at the time of switch or initiate standard SC dosing. There is a pressing need to understand dosing patterns in patients transitioning from escalated IV dosing to SC administration and patient outcomes after switching to SC administration based on dosing.\n\nThe proposed study would meet current gaps in literature by evaluating 1) clinical outcomes in patients with CD and UC switching from IV to SC vedolizumab and 2) dosing patterns from standard or escalated IV dosing at baseline to standard or escalated SC dosing, including switching practices and outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were identified if they were seen in the VUMC IBD clinic as part of normal clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Crohn's Disease or Ulcerative Colitis referred to start SC vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab\n* Age 18 years old or older\n\nExclusion Criteria:\n\n* Patients prescribed SC vedolizumab from a non-VUMC provider\n* Patients lost to follow-up or change in provider or medication before SC formulation started"}, 'identificationModule': {'nctId': 'NCT07123350', 'briefTitle': 'Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Evolving Biologic Administration: Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '250579'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IV to SC switch', 'description': "Patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) referred to switch to subcutaneous vedolizumab from IV vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab", 'interventionNames': ['Drug: Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care']}], 'interventions': [{'name': 'Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care', 'type': 'DRUG', 'description': 'This study does not include any subject enrollment or randomization. This is a retrospective cohort review of patients referred to start subcutaneous vedolizumab from a VUMC IBD provider.', 'armGroupLabels': ['IV to SC switch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Miranda Z. Kozlicki, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Chelsea P. Renfro, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Autumn D. Zuckerman, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study does not meet the criteria for an Applicable Clinical Trial (ACT) under 42 CFR 11.22(b) as this study is not interventional (a clinical trial)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals U.S.A., Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist for Research and Engagement', 'investigatorFullName': 'Chelsea Renfro', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}