Cure8 trial brief
Why This Matters
This study will collect real-world data on etrasimod, an oral S1P receptor modulator, in people with ulcerative colitis, using patient-reported symptom measures over one year — information that may help patients and clinicians understand how the drug performs outside of tightly controlled clinical trials.
Who Should Pay Attention
Adults with ulcerative colitis considering or prescribed etrasimod, clinicians who treat UC, and researchers interested in real-world effectiveness of S1P modulators.
Study Snapshot
What To Know
This is a real-world, non-interventional observational study registered on ClinicalTrials.gov that will follow adults with moderate-to-severe ulcerative colitis who are prescribed etrasimod as part of routine care.
Participants complete online patient-reported questionnaires over 52 weeks; assessments otherwise follow standard of care and there is a 28-day safety follow-up. The study will analyze symptomatic remission at weeks 12 and 52 using PRO2 components (stool frequency and rectal bleeding).
Planned enrollment is 360 and the registry status is ACTIVE_NOT_RECRUITING. Eligibility excludes prior exposure to etrasimod and requires participants be willing and able to complete electronic questionnaires.
This record is a trial registry entry (Pfizer-listed locations in Canada) describing design and outcomes to be collected; it does not report results or safety findings.
Keep In Mind
This is a non-interventional observational registry record and does not present trial results. The entry describes planned assessments and eligibility; interpretation of effectiveness or safety requires waiting for study completion and data release. The record is limited to participating sites listed and to patients able to complete electronic questionnaires.
Source Details
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.