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NCT06398626Recruiting

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

Pfizer

Start Date

9/17/2024

Completion Date

7/7/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to 64 years

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

Interventions

DRUG

Etrasimod

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Conditions

Colitis, Ulcerative

Locations

Reddy GI Associates

Mesa, Arizona 85206

United States

Scripps Clinic Torrey Pines

La Jolla, California 92037

United States

United Medical Doctors

Los Alamitos, California 90720

United States

United Medical Doctors

Los Alamitos, California 90720

United States

Rocky Mountain Gastroenterology

Littleton, Colorado 80120

United States

Digestive and Liver Center of Florida Kissimmee

Kissimmee, Florida 34741

United States

Gastro Florida

Lutz, Florida 33558

United States

Orlando Health/Digestive Health Institute

Orlando, Florida 32806

United States

Feinberg School of Medicine Northwestern University

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Suburban Gastroenterology Ltd

Naperville, Illinois 60540

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

Virtua Health

Marlton, New Jersey 08053

United States

NYU Langone Health

New York, New York 10016

United States

Lenox Hill Hospital, Northwell Health

New York, New York 10075

United States

University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

Chapel Hill, North Carolina 27599

United States

OnSite Clinical Solutions, LLC

Charlotte, North Carolina 28211

United States

University of Cincinnati College of Medicine

Cincinnati, Ohio 45267

United States

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio 44145

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425

United States

Houston Endoscopy & Research Center

Houston, Texas 77079

United States

BI Research Center

Houston, Texas 77084

United States

Brooke Army Medical center

San Antonio, Texas 78234

United States

Brooke Army Medical center

San Antonio, Texas 78234

United States

GI Alliance Research

Southlake, Texas 76092

United States

Washington Gastroenterology

Tacoma, Washington 98405

United States

WVU Medicine J.W Ruby Memorial Hospital

Morgantown, West Virginia 26505

United States