Cure8 trial brief
This trial tests a common real-world question: switching from IV induction to subcutaneous vedolizumab maintenance in adults with moderate-to-severe UC or CD and measures short-term remission and longer-term treatment experience in community clinics.
Adult patients with moderate-to-severe UC or Crohn's disease; patients on or considering vedolizumab; gastroenterology clinicians; clinical researchers interested in postmarketing biologic studies.
This ClinicalTrials.gov record describes a recruiting, phase 4 study of vedolizumab where participants receive two IV induction doses (Weeks 0 and 2) and may transition to subcutaneous vedolizumab starting at Week 6, continuing every 2 weeks to Week 50.
The study will assess PRO-2 remission in Crohn's disease and Mayo score–based measures in ulcerative colitis at Week 14; participants not responding by then may stop vedolizumab and switch therapies. Planned enrollment is about 400 adult participants across multiple US community sites.
The record lists typical inclusion (moderate-to-severe disease, prior inadequate response/intolerance to steroids, immunomodulators, or advanced therapy) and exclusion criteria (prior anti-integrin exposure, failure of >2 prior advanced treatments, certain recent therapies, relevant safety concerns per the vedolizumab label).
The trial is sponsored/organized in association with Takeda and is presented as Phase 4 (postmarketing) community-setting research.
This is a ClinicalTrials.gov trial record (phase 4, recruiting) describing planned treatment and outcomes; it does not report study results. The study follows vedolizumab US prescribing information for safety considerations and excludes prior anti-integrin exposure.
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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