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

RecruitingObservational study

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

Who can join

Ages 18 to 64 · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 300 · Started: Sep 17, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06398626

Locations in the U.S.

ArizonaReddy GI Associates, Mesa
CaliforniaScripps Clinic Torrey Pines, La Jolla
United Medical Doctors, Los Alamitos
United Medical Doctors, Los Alamitos (Not yet recruiting)
ColoradoRocky Mountain Gastroenterology, Littleton
FloridaDigestive and Liver Center of Florida Kissimmee, Kissimmee
Orlando Health/Digestive Health Institute, Orlando (Not yet recruiting)
IllinoisFeinberg School of Medicine Northwestern University, Chicago
Rush University Medical Center, Chicago
Suburban Gastroenterology Ltd, Naperville
MarylandMGG Group Co., Inc., Chevy Chase Clinical Research, Chevy Chase
Woodholme Gastroenterology Associates PA, Glen Burnie
New JerseyVirtua Health, Marlton
New YorkLenox Hill Hospital, Northwell Health, New York
NYU Langone Health, New York
North CarolinaUniversity of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology, Chapel Hill
OnSite Clinical Solutions, LLC, Charlotte
OhioUniversity of Cincinnati College of Medicine, Cincinnati
Gastro Intestinal Research Institute of Northern Ohio, LLC, Westlake
South CarolinaMedical University of South Carolina (MUSC), Charleston
TexasBI Research Center, Houston
Houston Endoscopy & Research Center, Houston
Brooke Army Medical center, San Antonio
Brooke Army Medical center, San Antonio (Not yet recruiting)
GI Alliance Research, Southlake
WashingtonWashington Gastroenterology, Tacoma
West VirginiaWVU Medicine J.W Ruby Memorial Hospital, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.