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

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Inflammatory Bowel Disease (IBD)Crohn's DiseaseUlcerative Colitis
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."

Trial Locations (6)

10016

RECRUITING

New York University, New York

20815

NOT_YET_RECRUITING

Capital Digestive Care, Chevy Chase

27599

RECRUITING

University of North Carolina, Chapel Hill

37232

NOT_YET_RECRUITING

Vanderbilt University, Nashville

45219

NOT_YET_RECRUITING

University of Cincinnati, Cincinnati

70112

NOT_YET_RECRUITING

Tulane University, New Orleans

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Mercy Medical Center

OTHER

NCT06750731 - Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention | Biotech Hunter | Biotech Hunter