Cure8 trial brief
This registry will track how people with moderate to severe ulcerative colitis do on risankizumab in routine Japanese clinical practice, which may provide information about real-world remission rates and longer-term outcomes up to 3 years.
Patients with moderate to severe UC starting risankizumab; clinicians prescribing biologics; researchers studying real-world biologic outcomes.
This ClinicalTrials.gov record describes a non-interventional observational registry in Japan enrolling about 200 adults (and adolescents ≥15 years) who are starting risankizumab for moderate to severe ulcerative colitis as part of routine care.
Participants will be followed up to 156 weeks with assessments including clinical remission by a Partial Adapted Mayo Score at Week 52. The study captures real-world treatment use and patient-reported outcomes collected with a smart device.
The record states risankizumab is approved for UC and that prescribing is determined by the treating physician before study entry; the study does not assign treatment. Because this is observational, it aims to describe outcomes and disease activity in routine practice rather than test efficacy in a randomized trial.
Observational design means no randomization or assigned treatment; the decision to prescribe risankizumab occurs before study entry. The record describes planned measurements and follow-up but does not include trial results.
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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