A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
NCT ID: NCT06294925
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
360 participants
OBSERVATIONAL
2024-05-08
2027-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients receiving etrasimod for ulcerative colitis
Etrasimod
As provided in real world practice
Interventions
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Etrasimod
As provided in real world practice
Eligibility Criteria
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Inclusion Criteria
* Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria
* 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 (eg, 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:
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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) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator.
* Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection 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.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Vancouver Coastal Health
Vancouver, British Columbia, Canada
Providence Health Care (PHC)
Vancouver, British Columbia, 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
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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EFFECT-UC
Identifier Type: OTHER
Identifier Source: secondary_id
C5041041
Identifier Type: -
Identifier Source: org_study_id
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