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NCT06294925Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
360 (estimated)
First submitted
28 Feb 2024
Start date
8 May 2024
Primary completion date
13 May 2027
Lead sponsor
Pfizer
NCT number
NCT06294925

What you commit to

  • Study type: Observational
  • Planned participants: 360
  • From 8 May 2024 to the primary completion date, 13 May 2027
  • 41 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 (eg, colectomy) within 12 weeks.
    • 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:
    • <!-- -->
    • 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) 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.

Other illness

  • Presence of clinical findings suggestive of Crohn's disease.

Other

  • 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.

Who the study is looking for

  • Male and female patients ≥18 and \<65 years of age at baseline
  • 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.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kelowna Gastroenterology Associates
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KelownaCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
CHUM
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MontrealCanadaUnknown status
Montreal General Hospital
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MontrealCanadaUnknown status
Hôpital du Sacré-Cœur de Montréal
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MontrealCanadaUnknown status
Columbia Medical Building
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New WestminsterCanadaUnknown status
Ottawa Hospital
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OttawaCanadaUnknown status
Richmond Hospital
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RichmondCanadaUnknown status
Vancouver Coastal Health
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VancouverCanadaUnknown status
Providence Health Care (PHC)
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VancouverCanadaUnknown status
MVZ Gastroenterologie Aachen
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AachenGermanyUnknown status
Praxis Heil und Müller
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AndernachGermanyUnknown status
MVZ für Gastroenterologie am Bayerischen Platz
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BerlinGermanyUnknown status
Evangelisches Krankenhaus Kalk
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CologneGermanyUnknown status
MVZ Dachau
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DachauGermanyUnknown status
Interdisziplinares Crohn Colitis Centrum
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Frankfurt am MainGermanyUnknown status
Gastrofreiburg
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Freiburg im BreisgauGermanyUnknown status
Facharztpraxis für Gastroenterologie
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GrevenbroichGermanyUnknown status
Studiengesellschaft BSF UG.
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HalleGermanyUnknown status
Praxis für Gasteroenterologie
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HeidelbergGermanyUnknown status
Gastroenterologie OpernstraBe
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KasselGermanyUnknown status
Praxis für Gasteroenterologie Lübeck
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LübeckGermanyUnknown status
Klinikum Luneburg
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LüneburgGermanyUnknown status
Internistische Praxengemeinschaft Oldenburg
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OldenburgGermanyUnknown status
Magen-Darm-Zentrum Remscheid
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RemscheidGermanyUnknown status
CED am Rhein
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WesselingGermanyUnknown status
Northern Care Alliance NHS Foundation Trust, Greater Manchester
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CrumpsallUnited KingdomUnknown status
Western General Hospital
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EdinburghUnited KingdomUnknown status
NHS Greater Glasgow and Clyde
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GlasgowUnited KingdomUnknown status
Tunbridge Wells Hospital
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KentUnited KingdomUnknown status
University College London Hospital
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LondonUnited KingdomUnknown status
St Mark's Hospital
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LondonUnited KingdomUnknown status
Imperial College Healthcare NHS
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LondonUnited KingdomUnknown status
Barts Health NHS Trust , The Royal London Hospital
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LondonUnited KingdomUnknown status
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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LondonUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
St George's Hospital - St George's Healthcare Nhs Trust
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LondonUnited KingdomUnknown status
Royal Gwent Hospital
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NewportUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust, Queens Medical Centre
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NottinghamUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomUnknown status
Southampton University Hospitals NHS Trust
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SouthamptonUnited KingdomUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.