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An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Sponsor: Pfizer
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
Conditions
Interventions
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