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An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the effects of etrasimod in adults ages 18 to 64 with moderate to severe ulcerative colitis (UC), a disease that causes swelling and sores in the large bowel. It is for people who have never taken etrasimod and whose doctor chooses it as their best treatment. Patients receive usual care and answer symptom surveys on their own device during the 52-week study, followed by 28 days of safety follow-up.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 64 years old when the study starts.
  • You have confirmed UC that is moderately to severely active, and your doctor prescribes etrasimod.
  • You or your legal representative sign and date a consent form after learning about the study.

Who can't join

  • You have signs of Crohn’s disease, another disease that causes swelling in the digestive tract.
  • Your doctor thinks you will likely need hospital care or surgery for UC within 12 weeks.
  • You currently have a sudden, severe UC flare, very severe bowel swelling, or toxic megacolon (dangerous widening of the large bowel).
  • You have a stoma (an opening in the belly for waste) or planned UC surgery that requires a hospital stay.
  • You have taken etrasimod before, including in a clinical study.
  • You currently take methotrexate; azathioprine, mercaptopurine, or tioguanine; biologic medicines that block TNF, integrins, or cytokines; filgotinib, tofacitinib, or upadacitinib; or another S1P receptor modulator. These are types of medicines that affect the immune system.
  • You cannot or do not want to download or use the online survey tool on your own device.
  • You are study-site staff or a Pfizer employee directly involved in the study, site staff supervised by the study doctor, or a family member of one of these people.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (28)

AZ

CA

CO

FL

IL

MD

NC

NJ

NY

OH

SC

TX

WA

WV