Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorShowa Inan General Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Etrasimod administration

    Drug

    2 mg of Etrasimod is orally administered everyday.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: elderly patients (aged 65 years or older) with active ulcerative colitisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint: Clinical remission rate at 4 weeks (Clinical activity Index score <4) (max.29, min. 0)

Time frame
4 weeks

Secondary outcomes

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

MES: Min. 0, Max 3, UCEIS: Min. 0, Max 8

Time frame
52 weeks

Other outcomes

Sponsors and contacts

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