An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
ENDEAVOUR-UC
A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
2 other identifiers
observational
300
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
September 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 7, 2028
April 28, 2026
April 1, 2026
3 years
April 30, 2024
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with symptomatic remission
Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0
Week 12
Secondary Outcomes (13)
Proportion of patients with symptomatic remission
Weeks 24, 36, 52
Proportion of patients with symptomatic response
Weeks 12, 24, 36, 52
Proportion of patients with symptomatic response
Weeks 12, 24, 36, 52
Proportion of patients with clinical remission
Weeks 12, 24, 36, 52
Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission)
Weeks 24, 36, 52
- +8 more secondary outcomes
Study Arms (1)
Adult patients with ulcerative colitis taking etrasimod
Interventions
As provided in real world practice
Eligibility Criteria
Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the United States etrasimod prescribing information and independent from the decision to enroll the patient in this study.
You may qualify if:
- 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
You may not qualify if:
- The presence of clinical findings suggestive of Crohn's disease
- Severe extensive colitis evidenced by:
- Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks
- Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
- Patients with a stoma or planned UC surgical intervention requiring hospitalization
- Prior/Concomitant Therapy:
- Any previous exposure to etrasimod, including participation in the etrasimod clinical program
- Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
- Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator
- Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (22)
Reddy GI Associates
Mesa, Arizona, 85206, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
United Medical Doctors
Los Alamitos, California, 90720, United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120, United States
Gastro Florida
Lutz, Florida, 33558, United States
Orlando Health/Digestive Health Institute
Orlando, Florida, 32806, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Woodholme Gastroenterology Associates PA
Glen Burnie, Maryland, 21061, United States
NYU Langone Health
New York, New York, 10016, United States
Lenox Hill Hospital, Northwell Health
New York, New York, 10075, United States
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28211, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, 44145, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Houston Endoscopy & Research Center
Houston, Texas, 77079, United States
BI Research Center
Houston, Texas, 77084, United States
Brooke Army Medical center
San Antonio, Texas, 78234, United States
GI Alliance Research
Southlake, Texas, 76092, United States
Washington Gastroenterology
Tacoma, Washington, 98405, United States
WVU Medicine J.W Ruby Memorial Hospital
Morgantown, West Virginia, 26505, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2024
First Posted
May 3, 2024
Study Start
September 17, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
July 7, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.