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

Recruiting now

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT06398626

Run by

Pfizer

People needed

300

Starts

2024-09-17

Expected to finish

2028-07-07

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years and < 65 years at baseline
• Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
• 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

You may not qualify if…

• The presence of clinical findings suggestive of Crohn's disease
• Severe extensive colitis evidenced by:
• 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
• Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
• Patients with a stoma or planned UC surgical intervention requiring hospitalization
• Prior/Concomitant Therapy:
• Any previous exposure to etrasimod, including participation in the etrasimod clinical program
• Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
• 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
• 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
• 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

Where it is running

• WVU Medicine J.W Ruby Memorial Hospital — Morgantown, West Virginia, United States (enrolling)
• Scripps Clinic Torrey Pines — La Jolla, California, United States (enrolling)
• United Medical Doctors — Los Alamitos, California, United States (enrolling)
• Brooke Army Medical center — San Antonio, Texas, United States (enrolling)
• GI Alliance Research — Southlake, Texas, United States (enrolling)
• Washington Gastroenterology — Tacoma, Washington, United States (enrolling)
• Reddy GI Associates — Mesa, Arizona, United States (enrolling)
• Rocky Mountain Gastroenterology — Littleton, Colorado, United States (enrolling)
• Digestive and Liver Center of Florida Kissimmee — Kissimmee, Florida, United States (enrolling)
• Feinberg School of Medicine Northwestern University — Chicago, Illinois, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Suburban Gastroenterology Ltd — Naperville, Illinois, United States (enrolling)
• MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase, Maryland, United States (enrolling)
• Woodholme Gastroenterology Associates PA — Glen Burnie, Maryland, United States (enrolling)
• Virtua Health — Marlton, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Lenox Hill Hospital, Northwell Health — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology — Chapel Hill, North Carolina, United States (enrolling)
• OnSite Clinical Solutions, LLC — Charlotte, North Carolina, United States (enrolling)
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States (enrolling)
• Gastro Intestinal Research Institute of Northern Ohio, LLC — Westlake, Ohio, United States (enrolling)
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (enrolling)
• Houston Endoscopy & Research Center — Houston, Texas, United States (enrolling)
• BI Research Center — Houston, Texas, United States (enrolling)
• United Medical Doctors — Los Alamitos, California, United States

Full record on ClinicalTrials.gov

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