Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting study of Ulcerative Colitis and Inflammatory Bowel Disease (IBD), sponsored by Mercy Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
The primary outcome of the proposed study will be the difference in mean medication possession ratio (MPR) between intravenous and subcutaneous vedolizumab during the 22-week study. The mean MPR will be calculated as follows: MPR = number days' supply of medication obtained over observation period/total number days in observation period.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2026-09-30 |
What NCT06750731 shows while recruiting
NCT06750731 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06750731's enrollment target sits among peer trials
200 43rd of 122 higher than 79 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
RECRUITING · Phase 2
-
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
RECRUITING · NA
-
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
RECRUITING · NA
-
Registry and Biorepository for IBD in Central Texas
RECRUITING
-
Nicotinamide Riboside in Ulcerative Colitis
RECRUITING · NA
-
Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI