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Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention

NCT06750731 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-05-08

No results posted yet for this study

Summary

The goal of this observational study is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization in patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, and inflammatory bowel disease type undetermined) initiating therapy with vedolizumab (Entvyio). The main questions it aims to answer are:

1. Assess and compare adherence to intravenous (IV) and subcutaneous vedolizumab maintenance therapy in patients with IBD using a novel remote monitoring system.
2. Assess symptom response to vedolizumab post induction (week 6-8) and during maintenance therapy (week 22) using a novel remote monitoring system.
3. Assess time to response to vedolizumab during induction (weeks 0-6) using a novel remote monitoring system.

Researchers will compare medication adherence between participants using IV and subcutaneous vedolizumab maintenance therapy to see if adherence is lower with self-administration.

Participants will be asked to register adherence to medication using the novel remote monitoring system each time they take a dose of vedolizumab and to respond to two questions about bowel symptoms weekly for the first 6 weeks after starting vedolizumab then monthly thereafter for 6 months. Additionally, participants will be asked to enter information regarding demographics and social determinants of health at baseline and other variables listed below at baseline and at weeks 2, 6, 14, and 22 post baseline unless otherwise denoted:

* MARS-5
* Healthcare utilization (22 weeks only)
* Harvey Bradshaw Index (Crohn's disease only)
* Simple clinical colitis activity index (Ulcerative colitis only)
* PROMIS Global Health Scale
* PROMIS Anxiety
* PROMIS Depression
* PROMIS Sleep Disturbance
* PROMIS Pain Interference
* PROMIS Physical Function
* IBD Self-Efficacy
* Attitudinal Survey (22 weeks only)

Conditions

Interventions

DEVICE

Tappt

Tappt is a web-based system designed to record participants medication taking behavior and bowel symptoms. Participants will be assigned smart labels for their specific vedolizumab regimen, which will be used by participants to record their vedolizumab use. Participants will be shipped smart labels to be affixed to an IV "card" for the first three infusions and for subsequent infusions or injections. At the time of a vedolizumab dose, participants will scan the smart label by tapping it with their mobile device to verify that they are taking the medication. Each day that vedolizumab is due, patients will receive a reminder through SMS message. If participants fail to scan the label at a given time (as expected by their specific medication regimen), they will receive an end of day text message reminder. Participants will also complete a patient reported outcome assessment at baseline, weekly for 6 weeks, and then monthly for the entire 22 weeks of the study triggered by the system.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Mercy Medical Center

    lead OTHER

Principal Investigators

  • Raymond K Cross, MD, MS · Mercy Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750731 on ClinicalTrials.gov