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

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. 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.

Conditions

Colitis, Ulcerative

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Colitis, Ulcerative
Intervention / Treatment

-

Contacts and Locations

Mesa

Reddy GI Associates, Mesa, Arizona, United States, 85206

Valencia

Amicis Research Center, Valencia, California, United States, 91355

Littleton

Rocky Mountain Gastroenterology, Littleton, Colorado, United States, 80120

Clearwater

Gastro Florida, Clearwater, Florida, United States, 33756

Lutz

Gastro Florida, Lutz, Florida, United States, 33558

Pembroke Pines

Best Choice Medical Research Service, Pembroke Pines, Florida, United States, 33024

Snellville

EBGS Clinical Research Center, Snellville, Georgia, United States, 30078

Chevy Chase

MGG Group Co., Inc., Chevy Chase Clinical Research, Chevy Chase, Maryland, United States, 20815

Glen Burnie

Woodholme Gastroenterology Associates PA, Glen Burnie, Maryland, United States, 21061

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 has been informed of all pertinent aspects of the study
  • 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

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-09-15