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

NCT07123350 | Active Not Recruiting FDA Drug

• 1 other identifier: 250579
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Inflammatory Bowel Disease; Health-system Specialty Pharmacy; Vedolizumab

Outcome Measures

Primary Outcomes (1)

• Clinical Remission

  Defined as clinical remission assessed and written by provider in the office visit note

  baseline with IV dosing, and 3, 6, 9, 12 months after switching to SC

Secondary Outcomes (9)

• Endoscopic Remission

  at baseline with IV dosing and within 12 months after switching to SC

• Dosing patterns of IV dose/frequency and SC dose/frequency

  At baseline and up to 12 months after switching

• SIBDQ score

  Baseline and 12 months post switch to SC

• Persistence to SC formulation

  Up to 12 months after switching

• Adverse events to vedolizumab SC

  Up to 12 months after switching

Other Outcomes (3)

• Hospitalization and ED visits related to IBD

  12 months before and after switch to SC

• Adverse events reported after switching to SC

  12 months post switch to SC

• Drug trough levels before and after switching to SC

  12 months before and after switching to SC

Study Arms (1)

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

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

Interventions

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

IV to SC switch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were identified if they were seen in the VUMC IBD clinic as part of normal clinical practice

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Takeda Pharmaceuticals U.S.A., Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37211, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Miranda Z. Murray, PharmD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Autumn D. Zuckerman, PharmD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist for Patient Care Improvement

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: October 16, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)