Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis

Showa Inan General Hospital30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis (Disorder)

Interventions

Etrasimod administrationDRUG

2 mg of Etrasimod is orally administered everyday.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Showa Inan General Hospital

Komagane, Nagano, Japan

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

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

Time frame: 52 weeks

Central Contacts

Norio Saegusa

CONTACT

81265822121 ikyoku.tosho@sihp.jp

Data from ClinicalTrials.gov

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