An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Observational · No treatment assigned · 28 sites · Pfizer
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colitis, Ulcerative. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 64
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2024-09-17.
- Main results expected around 2027-10-01 (estimate from the record).
- 28 study sites listed (24 marked recruiting) in United States.
Main thing being measured
- Proportion of patients with symptomatic remission (Week 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colitis, Ulcerative |
| Lead sponsor | Pfizer |
| Enrollment | 300 (estimated) |
| Start date | 2024-09-17 |
| Primary completion (est.) | 2027-10-01 |
| First posted | 2024-05-03 |
| Last updated | 2026-07-09 |
| Official title | A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC) |
| ClinicalTrials.gov ID | NCT06398626 |
Interventions
- Etrasimod (Drug)
As provided in real world practice
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Age ≥ 18 years and < 65 years at baseline 2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC 3. 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 Criteria: 1. The presence of clinical findings suggestive of Crohn's disease 2. Severe extensive colitis evidenced by: 1. 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 2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization 4. Prior/Concomitant Therapy: 1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program 2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine) 3. 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 5. 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 6. 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
Locations (28)
Show all 28 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Reddy GI Associates | Mesa, Arizona | United States | Recruiting |
| Scripps Clinic Torrey Pines | La Jolla, California | United States | Recruiting |
| United Medical Doctors | Los Alamitos, California | United States | Recruiting |
| United Medical Doctors | Los Alamitos, California | United States | Not yet recruiting |
| Rocky Mountain Gastroenterology | Littleton, Colorado | United States | Recruiting |
| Digestive and Liver Center of Florida Kissimmee | Kissimmee, Florida | United States | Recruiting |
| Gastro Florida | Lutz, Florida | United States | Terminated |
| Orlando Health/Digestive Health Institute | Orlando, Florida | United States | Not yet recruiting |
| Feinberg School of Medicine Northwestern University | Chicago, Illinois | United States | Recruiting |
| Rush University Medical Center | Chicago, Illinois | United States | Recruiting |
| Suburban Gastroenterology Ltd | Naperville, Illinois | United States | Recruiting |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase, Maryland | United States | Recruiting |
| Woodholme Gastroenterology Associates PA | Glen Burnie, Maryland | United States | Recruiting |
| Virtua Health | Marlton, New Jersey | United States | Recruiting |
| NYU Langone Health | New York, New York | United States | Recruiting |
| Lenox Hill Hospital, Northwell Health | New York, New York | United States | Recruiting |
| University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology | Chapel Hill, North Carolina | United States | Recruiting |
| OnSite Clinical Solutions, LLC | Charlotte, North Carolina | United States | Recruiting |
| University of Cincinnati College of Medicine | Cincinnati, Ohio | United States | Recruiting |
| Gastro Intestinal Research Institute of Northern Ohio, LLC | Westlake, Ohio | United States | Recruiting |
| Medical University of South Carolina (MUSC) | Charleston, South Carolina | United States | Recruiting |
| Houston Endoscopy & Research Center | Houston, Texas | United States | Recruiting |
| BI Research Center | Houston, Texas | United States | Recruiting |
| Brooke Army Medical center | San Antonio, Texas | United States | Recruiting |
| Brooke Army Medical center | San Antonio, Texas | United States | Not yet recruiting |
| GI Alliance Research | Southlake, Texas | United States | Recruiting |
| Washington Gastroenterology | Tacoma, Washington | United States | Recruiting |
| WVU Medicine J.W Ruby Memorial Hospital | Morgantown, West Virginia | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.