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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

Study acronym: MONITOR
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2026 → Sep 30, 2027
See other at-risk trials from Mercy Medical Center

Record History

  1. Primary and study completion pushed from Sep 30, 2026 to Sep 30, 2027 Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 12 of 17 entries · Study description revised · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 12 of 17 entries
    • Study description revised
    • Study sites revised (6)
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2025 to May 5, 2025 · Site details revised at 6 of 6 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2025 to May 5, 2025
    • Site details revised at 6 of 6 sites
  3. Eligibility criteria revised Secondary endpoints: details revised at 7 of 17 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 7 of 17 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06750731
Lead Sponsor Mercy Medical Center
Collaborators: Takeda
Conditions Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov