Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etrasimod administration.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (Disorder). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study on the Efficacy and Safety of a Novel Oral Drug, Etrasimod, in Elderly Patients With Ulcerative Colitis
Overview
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
- Drug Etrasimod administration
2 mg of Etrasimod is orally administered everyday.
Primary outcome measures
- Primary endpoint: Clinical remission rate at 4 weeks (Clinical activity Index score <4) (max.29, min. 0) [Time frame: 4 weeks]
Secondary outcome measures (1)
- 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 [Time frame: 52 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Showa Inan General Hospital — Komagane
Identifiers
NCT: NCT07243639 · Etrasimod in elderly UC