Cure8 trial brief
Adherence to biologic therapy can affect how well treatment controls IBD; understanding whether self-administered subcutaneous vedolizumab has different adherence than IV infusion could influence treatment choices and support needs.
The study also tests a remote digital system to monitor dosing and symptoms, which could make follow-up easier for patients and clinics.
Patients on or considering vedolizumab (IV or subcutaneous); clinicians prescribing biologics; researchers studying adherence or digital health in IBD.
This is a multicenter, open-label observational study (recruiting) that will track adherence, symptoms, and healthcare use over 22 weeks in people with IBD starting vedolizumab (IV or subcutaneous) using a remote digital monitoring system (Tappt smart labels and web/SMS reminders).
Participants scan smart labels at dosing, complete brief symptom questionnaires weekly for 6 weeks then monthly through week 22, and provide PROMs and other measures at baseline, 2, 6, 14, and 22 weeks. The study compares adherence between IV and subcutaneous vedolizumab and measures time-to-response and symptom changes during induction and maintenance.
Participants with ostomies, total/subtotal colectomy, or short bowel syndrome are excluded because bowel frequency cannot be reliably measured. Concomitant IBD meds may be continued or added; if vedolizumab is replaced the new medication will be tracked similarly.
The trial uses centralized electronic data capture and smart labels to reduce measurement bias and support remote verification of dosing.
This is a registered, multicenter observational study (recruiting) focusing on feasibility and short-term outcomes (22 weeks). It describes procedures and planned measurements but does not present results. The remote monitoring tool is a proprietary system (Tappt) used for label scanning and reminders.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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