About this trial
Eligible patients will be identified in regular clinical practice. After providing thorough explanation and obtaining voluntary written informed consent, the clinical course, adverse events, endoscopic findings, and histopathological changes in biopsy specimens after Etrasimod administration will be prospectively collected and analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with active ulcerative colitis
Disqualifiers
the presence of acute or chronic renal failure, chronic heart disease, pulmonary infection, liver cirrhosis, colorectal cancer, autoimmune disease, and infectious disease
Trial design
Single group
Treatments tested in this trial
Etrasimod administration
Drug2 mg of Etrasimod is orally administered everyday.
Treatment groups
Trial outcomes
Primary outcomes
Primary endpoint: Clinical remission rate at 4 weeks (Clinical activity Index score <4) (max.29, min. 0)
Secondary outcomes
Secondary endpoints: Endoscopic improvement rate at 52 weeks (Mayo Endoscopic Subscore (MES) <1 or improved (Ulcerative colitis endoscopic of severity, UCEIS), and incidence of adverse events during the study
MES: Min. 0, Max 3, UCEIS: Min. 0, Max 8
Sponsors and contacts
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