A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• Age ≥ 18 years and \< 65 years at baseline
• Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
• Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study
Locations
United States
Arizona
Reddy GI Associates
RECRUITING
Mesa
California
Scripps Clinic Torrey Pines
NOT_YET_RECRUITING
La Jolla
United Medical Doctors
NOT_YET_RECRUITING
Los Alamitos
Amicis Research Center
RECRUITING
Valencia
Colorado
Rocky Mountain Gastroenterology
RECRUITING
Littleton
Florida
Gastro Florida
TERMINATED
Lutz
Orlando Health/Digestive Health Institute
NOT_YET_RECRUITING
Orlando
Best Choice Medical Research Service
RECRUITING
Pembroke Pines
University of South Florida
NOT_YET_RECRUITING
Tampa
Maryland
MGG Group Co., Inc., Chevy Chase Clinical Research
RECRUITING
Chevy Chase
Woodholme Gastroenterology Associates PA
RECRUITING
Glen Burnie
North Carolina
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
RECRUITING
Chapel Hill
New York
Lenox Hill Hospital, Northwell Health
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
University of Cincinnati College of Medicine
RECRUITING
Cincinnati
Gastro Intestinal Research Institute of Northern Ohio, LLC
NOT_YET_RECRUITING
Westlake
Texas
BI Research Center
RECRUITING
Houston
Houston Endoscopy & Research Center
RECRUITING
Houston
Brooke Army Medical center
NOT_YET_RECRUITING
San Antonio
GI Alliance Research
RECRUITING
Southlake
Washington
Washington Gastroenterology
RECRUITING
Tacoma
West Virginia
WVU Medicine J.W Ruby Memorial Hospital
NOT_YET_RECRUITING
Morgantown
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2024-09-17
Estimated Completion Date:2028-07-07
Participants
Target number of participants:300
Treatments
Adult patients with ulcerative colitis taking etrasimod