Ulcerative Colitis (Disorder)
Conditions
Brief summary
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.
Interventions
DRUGEtrasimod administration
2 mg of Etrasimod is orally administered everyday.
Sponsors
Showa Inan General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with active ulcerative colitis
Exclusion criteria
* the presence of acute or chronic renal failure, chronic heart disease, pulmonary infection, liver cirrhosis, colorectal cancer, autoimmune disease, and infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Clinical remission rate at 4 weeks (Clinical activity Index score <4) (max.29, min. 0) | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 52 weeks | MES: Min. 0, Max 3, UCEIS: Min. 0, Max 8 |
Countries
Japan
Contacts
CONTACTNorio Saegusa
Outcome results
None listed