RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-17
Study Completion:2027-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06398626

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years and \< 65 years at baseline
  2. 2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
  3. 3. Evidence of a personally signed and dated ICD indicating that the patient has been informed of all pertinent aspects of the study
  1. 1. The presence of clinical findings suggestive of Crohn's disease
  2. 2. Severe extensive colitis evidenced by:
  3. 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
  4. 2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
  5. 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization
  6. 4. Prior/Concomitant Therapy:
  7. 1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program
  8. 2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
  9. 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
  10. 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
  11. 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

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Reddy GI Associates
Mesa, Arizona, 85206
United States
Amicis Research Center
Valencia, California, 91355
United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
United States
Gastro Florida
Clearwater, Florida, 33756
United States
Gastro Florida
Lutz, Florida, 33558
United States
Best Choice Medical Research Service
Pembroke Pines, Florida, 33024
United States
EBGS Clinical Research Center
Snellville, Georgia, 30078
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
University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599
United States
Hightower Clinical Trial Services
Oklahoma City, Oklahoma, 73102
United States
BI Research Center
Houston, Texas, 77084
United States
Washington Gastroenterology
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-17
Study Completion Date2027-09-15

Study Record Updates

Study Start Date2024-09-17
Study Completion Date2027-09-15

Terms related to this study

Additional Relevant MeSH Terms

  • Colitis, Ulcerative