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NCT06750731 · ClinicalTrials.gov registry record

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

A clinical trial of Ulcerative Colitis and Inflammatory Bowel Disease (IBD), sponsored by Mercy Medical Center.

Recruiting
Registry status
200
Enrollment target
6
Study locations

NCT06750731 is a study of Ulcerative Colitis and Inflammatory Bowel Disease (IBD) that is actively recruiting participants, run by Mercy Medical Center. The registered enrollment target is 200 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT06750731, a study of Ulcerative Colitis and Inflammatory Bowel Disease (IBD), is actively recruiting participants, sponsored by Mercy Medical Center.

RECRUITING
Registry status
200 participants
Enrollment target
6
Study locations

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 Studied

Ulcerative Colitis Inflammatory Bowel Disease (IBD) Crohn's Disease

Interventions

  • DEVICE Tappt

Study Locations (6)

Louisiana

  • Tulane University - New Orleans

Maryland

  • Capital Digestive Care - Chevy Chase

New York

  • New York University - New York

North Carolina

  • University of North Carolina - Chapel Hill

Ohio

  • University of Cincinnati - Cincinnati

Tennessee

  • Vanderbilt University - Nashville

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2025-05-05
Est. Completion 2026-09-30

Sponsor

Mercy Medical Center

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06750731

The ClinicalTrials.gov registry entry for NCT06750731 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower). The listed sponsor is Mercy Medical Center, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Tappt is the first listed.

NCT06750731 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Louisiana, Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT06750731 about?

NCT06750731 is a clinical study titled "Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention". 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 diseas...

What is the current status of trial NCT06750731?

This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-05-05. Estimated completion is 2026-09-30.

What conditions does trial NCT06750731 study?

This clinical trial studies the following conditions: Ulcerative Colitis, Inflammatory Bowel Disease (IBD), Crohn's Disease.

What interventions are being tested in trial NCT06750731?

The interventions under investigation include: Tappt (DEVICE).

Who is sponsoring clinical trial NCT06750731?

This trial is sponsored by Mercy Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06750731 being conducted?

This trial has 6 study locations across Louisiana, Maryland, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.