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Search / Trial NCT07123350

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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 7, 2025

Trial Information

Current as of August 27, 2025

Not yet recruiting

Keywords

Inflammatory Bowel Disease Health System Specialty Pharmacy Vedolizumab

ClinConnect Summary

This study is looking at patients with inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, who are switching from receiving a medicine called vedolizumab through an IV (a needle in the vein) to getting it as a shot under the skin, known as subcutaneous (SC) administration. The researchers want to understand how patients are being dosed with this new method and how well they do after making the switch. This information will come from reviewing medical records of patients who start the shot form of vedolizumab as part of their regular care between September 2023 and December 2024.

To be part of this study, patients need to be 18 years or older, have Crohn’s disease or ulcerative colitis, and have been referred by a specific healthcare provider at Vanderbilt University Medical Center (VUMC) to start the shot form of vedolizumab. Patients who get the medicine from outside providers or who stop treatment or change doctors before starting the shot won’t be included. Since this study looks back at existing medical records, participants won’t need to change their treatment or do anything extra—they will simply have their health information reviewed to help doctors learn more about this new way of giving vedolizumab.

Gender

ALL

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

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Miranda Z. Kozlicki, PharmD

Principal Investigator

Vanderbilt University Medical Center

Chelsea P. Renfro, PharmD

Principal Investigator

Vanderbilt University Medical Center

Autumn D. Zuckerman, PharmD

Study Director

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported