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RECRUITING
NCT06398626

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

Official title: A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2024-09-17

Completion Date

2028-07-07

Last Updated

2025-12-08

Healthy Volunteers

No

Interventions

DRUG

Etrasimod

As provided in real world practice

Locations (22)

Reddy GI Associates

Mesa, Arizona, United States

Scripps Clinic Torrey Pines

La Jolla, California, United States

United Medical Doctors

Los Alamitos, California, United States

Amicis Research Center

Valencia, California, United States

Rocky Mountain Gastroenterology

Littleton, Colorado, United States

Gastro Florida

Lutz, Florida, United States

Orlando Health/Digestive Health Institute

Orlando, Florida, United States

Best Choice Medical Research Service

Pembroke Pines, Florida, United States

University of South Florida

Tampa, Florida, United States

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Woodholme Gastroenterology Associates PA

Glen Burnie, Maryland, United States

NYU Langone Health

New York, New York, United States

Lenox Hill Hospital, Northwell Health

New York, New York, United States

University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

Chapel Hill, North Carolina, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio, United States

Houston Endoscopy & Research Center

Houston, Texas, United States

BI Research Center

Houston, Texas, United States

Brooke Army Medical center

San Antonio, Texas, United States

GI Alliance Research

Southlake, Texas, United States

Washington Gastroenterology

Tacoma, Washington, United States

WVU Medicine J.W Ruby Memorial Hospital

Morgantown, West Virginia, United States