Cure8 trial brief
This trial tests whether people with UC in deep remission can safely stop JAK inhibitor therapy — potentially reducing long-term exposure and associated safety concerns while preserving disease control and quality of life.
Adults with ulcerative colitis in sustained deep remission who are taking JAK inhibitors (tofacitinib, upadacitinib, filgotinib); gastroenterologists and IBD clinicians; researchers studying treatment de-escalation strategies.
This is a phase IV randomized trial enrolling adults with UC in sustained steroid-free clinical and endoscopic remission on a stable dose of a JAK inhibitor (tofacitinib, upadacitinib, or filgotinib).
Participants will be randomized to either stop their JAK inhibitor or continue standard maintenance and followed for 104 weeks, with a composite primary endpoint at Week 52 that includes safety, efficacy, and patient satisfaction.
The study plans to enroll 224 participants and will assess relapse rates, endoscopic outcomes, quality of life, and predictors of successful discontinuation. The trial excludes people with known risk factors for VTE, MACE, or malignancy and requires fecal calprotectin ≤150 µg/g and Mayo endoscopic subscore = 0 at inclusion.
This is a phase IV, not-yet-recruiting randomized trial registered on ClinicalTrials.gov. As a trial record, it describes planned study design and endpoints but does not report results. The study focuses on patients already in strict deep remission and excludes those with VTE, cardiovascular, or malignancy risk factors.
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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