Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease

NCT ID: NCT07123350

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2026-03-31

Brief Summary

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.

Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and March 31, 2025, as part of normal patient care, will be retrospectively reviewed and analyzed.

Detailed Description

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.

Current 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.

There 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.

The 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.

Conditions

Inflammatory Bowel Disease (IBD); Crohn&Amp;#39;s Disease (CD); Ulcerative Colitis (UC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

IV to SC switch

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

Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care

Intervention Type: DRUG

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.

Interventions

Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• Age 18 years old or older

Exclusion Criteria

• Patients prescribed SC vedolizumab from a non-VUMC provider
• Patients lost to follow-up or change in provider or medication before SC formulation started

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals U.S.A., Inc.

UNKNOWN

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Chelsea Renfro

Clinical Pharmacist for Research and Engagement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miranda Z. Kozlicki, PharmD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Chelsea P. Renfro, PharmD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Autumn D. Zuckerman, PharmD

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

250579

Identifier Type: -

Identifier Source: org_study_id