RecruitingNCT06294925

A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis

Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC


Sponsor

Pfizer

Enrollment

360 participants

Start Date

May 8, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for 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 choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past. All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device. The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer. The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following patients with moderately to severely active ulcerative colitis (UC) who have been prescribed etrasimod — a medication that helps reduce inflammation in the colon by controlling immune cell movement. The goal is to track how well etrasimod works in real-world clinical practice. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of ulcerative colitis - Your doctor has independently prescribed etrasimod for moderately to severely active UC as per the approved label **You may NOT be eligible if...** - Your doctor suspects you have Crohn's disease rather than UC - Your colitis is so severe that surgery may be needed within 12 weeks - You have signs of acute severe colitis (hospitalization-level illness) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtrasimod

As provided in real world practice


Locations(34)

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Providence Health Care (PHC)

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

CHUM

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Gastroenterologie OpernstraBe

Kassel, Hesse, Germany

MVZ Gastroenterologie Aachen

Aachen, Germany

Praxis Heil und Müller

Andernach, Germany

MVZ für Gastroenterologie am Bayerischen Platz

Berlin, Germany

Evangelisches Krankenhaus Kalk

Cologne, Germany

MVZ Dachau

Dachau, Germany

Interdisziplinares Crohn Colitis Centrum

Frankfurt am Main, Germany

Facharztpraxis für Gastroenterologie

Grevenbroich, Germany

Studiengesellschaft BSF UG.

Halle, Germany

Praxis für Gasteroenterologie

Heidelberg, Germany

Praxis für Gasteroenterologie Lübeck

Lübeck, Germany

Klinikum Lüneburg

Lüneburg, Germany

Internistische Praxengemeinschaft Oldenburg

Oldenburg, Germany

Magen-Darm-Zentrum Remscheid

Remscheid, Germany

CED am Rhein

Wesseling, Germany

NHS Greater Glasgow and Clyde

Glasgow, Lanarkshire, United Kingdom

Nottingham University Hospitals NHS Trust, Queens Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Western General Hospital

Edinburgh, Scotland, United Kingdom

Northern Care Alliance NHS Foundation Trust, Greater Manchester

Crumpsall, United Kingdom

Tunbridge Wells Hospital

Kent, United Kingdom

Barts Health NHS Trust, The Royal London Hospital

London, United Kingdom

St. Mark's Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Kings College Hospital

London, United Kingdom

St George's Hospital - St George's Healthcare Nhs Trust

London, United Kingdom

Imperial College Healthcare NHS

London, United Kingdom

Southampton University Hospitals NHS Trust

Southampton, United Kingdom

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NCT06294925


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