Cure8 trial brief
This study will collect real-world data on how people with moderate-to-severe ulcerative colitis do after starting etrasimod, including symptom changes measured by patient questionnaires. That information can help patients and clinicians understand typical early symptomatic responses and safety in routine practice.
Adults with moderate-to-severe ulcerative colitis considering or prescribed etrasimod; gastroenterologists and IBD clinicians; researchers and registries tracking real-world drug outcomes.
This is an observational (non-randomized) study enrolling up to 300 adults already chosen by their physicians to start etrasimod. Treatment and follow-up visits occur per standard of care; the study adds scheduled electronic patient-reported outcome questionnaires about stool frequency and rectal bleeding.
The primary registered outcome is the proportion of patients with symptomatic remission at week 12, defined using a partial Modified Mayo Score.
This record excludes people with prior etrasimod exposure and certain concomitant immunosuppressive or biologic therapies; it also excludes patients with suspected Crohn’s disease, current acute severe ulcerative colitis, or planned colectomy. The study is labeled as recruiting at multiple US gastroenterology sites.
This is an observational, non-randomized registry (recruiting). It evaluates patient-reported symptom outcomes collected electronically and compares each participant’s disease activity before and after starting etrasimod. Results will reflect real-world prescribing and are not evidence of efficacy from a randomized trial.
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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