Observational study of etrasimod in adults with ulcerative colitis
Studies the effects of etrasimod in adults with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Key facts
- Where
- Chapel Hill, Charleston, Charlotte, Chevy Chase, Chicago, Cincinnati, Glen Burnie, Houston, Kissimmee, La Jolla, Littleton, Los Alamitos, Lutz, Marlton, Mesa, Morgantown, Naperville, New York, Orlando, San Antonio, Southlake, Tacoma, and Westlake, United StatesSee the 26 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT06398626, who can take part
Where in United States
- University of North Carolina at Chapel Hill, Division of Gastroenterology and HepatologyChapel Hill, United StatesTaking people
- Medical University of South Carolina (MUSC)Charleston, United StatesTaking people
- Onsite Clinical Solutions, LLCCharlotte, United StatesTaking people
- MGG Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, United StatesTaking people
- Feinberg School of Medicine Northwestern UniversityChicago, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of Cincinnati College of MedicineCincinnati, United StatesTaking people
- Woodholme Gastroenterology Associates PAGlen Burnie, United StatesTaking people
- BI Research CenterHouston, United StatesTaking people
- Houston Endoscopy & Research CenterHouston, United StatesTaking people
- Digestive and Liver Center of Florida KissimmeeKissimmee, United StatesTaking people
- Scripps Clinic Torrey PinesLa Jolla, United StatesTaking people
- Rocky Mountain GastroenterologyLittleton, United StatesTaking people
- United Medical DoctorsLos Alamitos, United StatesNot yet recruiting
- Gastro FloridaLutz, United StatesNo longer taking part
- Virtua HealthMarlton, United StatesTaking people
- Reddy GI AssociatesMesa, United StatesTaking people
- WVU Medicine J.W Ruby Memorial HospitalMorgantown, United StatesTaking people
- Suburban Gastroenterology LtdNaperville, United StatesTaking people
- Lenox Hill Hospital | Northwell HealthNew York, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- Orlando Health Digestive Health InstituteOrlando, United StatesNot yet recruiting
- Brooke Army Medical CenterSan Antonio, United StatesTaking people
- GI Alliance ResearchSouthlake, United StatesTaking people
- Washington GastroenterologyTacoma, United StatesTaking people
- Gastro Intestinal Research Institute of Northern Ohio, LLCWestlake, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT06398626
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
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.
Inclusion: 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.
Exclusion: 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; The presence of clinical findings suggestive of Crohn's disease; 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.