RecruitingNCT06398626

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

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


Sponsor

Pfizer

Enrollment

300 participants

Start Date

Sep 17, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following adult patients with moderate to severe ulcerative colitis (a type of inflammatory bowel disease) who are being prescribed etrasimod as part of their normal medical care. Researchers want to learn how well the medication works in real-world settings. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with ulcerative colitis (UC) - Your doctor has prescribed etrasimod for moderately to severely active UC **You may NOT be eligible if...** - You have signs of Crohn's disease instead of UC - Your colitis is so severe you may need hospitalization or surgery within 12 weeks - You have a colostomy or stoma - You have previously taken etrasimod - You are currently taking certain other UC medications (methotrexate, thiopurines, biologics, or other similar drugs) - You are unable to use a smartphone or computer to complete online questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtrasimod

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

Rocky Mountain Gastroenterology

Littleton, Colorado, United States

Gastro Florida

Lutz, Florida, United States

Orlando Health/Digestive Health Institute

Orlando, Florida, United States

Rush University Medical Center

Chicago, Illinois, 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

OnSite Clinical Solutions, LLC

Charlotte, 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

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 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

View Full Details on ClinicalTrials.gov

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NCT06398626


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