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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nashville, Tennessee, United States
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