A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis (EFFECT-UC)

March 24, 2026 updated by: Pfizer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Not yet recruiting
        • Vancouver Coastal Health
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • Providence Health Care (PHC)
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Not yet recruiting
        • London Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM
      • Montreal, Quebec, Canada, H3G 1A4
        • Not yet recruiting
        • Montreal General Hospital
  • Germany
      • Aachen, Germany, 52064
        • Recruiting
        • MVZ Gastroenterologie Aachen
      • Andernach, Germany, 56626
        • Recruiting
        • Praxis Heil und Müller
      • Berlin, Germany, 10825
        • Recruiting
        • MVZ für Gastroenterologie am Bayerischen Platz
      • Cologne, Germany, 51103
        • Recruiting
        • Evangelisches Krankenhaus Kalk
      • Dachau, Germany, 85221
        • Recruiting
        • MVZ Dachau
      • Frankfurt am Main, Germany, 60594
        • Recruiting
        • Interdisziplinares Crohn Colitis Centrum
      • Grevenbroich, Germany, 41515
        • Recruiting
        • Facharztpraxis für Gastroenterologie
      • Halle, Germany, 06108
        • Recruiting
        • Studiengesellschaft BSF UG.
      • Heidelberg, Germany, 69115
        • Recruiting
        • Praxis für Gasteroenterologie
      • Lübeck, Germany, 23560
        • Recruiting
        • Praxis für Gasteroenterologie Lübeck
      • Lüneburg, Germany, 21339
        • Recruiting
        • Klinikum Luneburg
      • Oldenburg, Germany, 10115
        • Recruiting
        • Internistische Praxengemeinschaft Oldenburg
      • Remscheid, Germany, 42859
        • Recruiting
        • Magen-Darm-Zentrum Remscheid
      • Wesseling, Germany, 50389
        • Recruiting
        • CED am Rhein
    • Hesse
      • Kassel, Hesse, Germany, 34117
        • Recruiting
        • Gastroenterologie OpernstraBe
  • United Kingdom
      • Crumpsall, United Kingdom, M8 5RB
        • Recruiting
        • Northern Care Alliance NHS Foundation Trust, Greater Manchester
      • Kent, United Kingdom, TN2 4QJ
        • Recruiting
        • Tunbridge Wells Hospital
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital
      • London, United Kingdom, HA1 3UJ
        • Recruiting
        • St. Mark's Hospital
      • London, United Kingdom, E1 1BB
        • Recruiting
        • Barts Health NHS Trust, The Royal London Hospital
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
      • London, United Kingdom, W2 1PG
        • Recruiting
        • Imperial College Healthcare NHS
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St George's Hospital - St George's Healthcare Nhs Trust
      • London, United Kingdom, SE59RS
        • Recruiting
        • Kings College Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton University Hospitals NHS Trust
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G4 0SF
        • Recruiting
        • NHS Greater Glasgow and Clyde
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Recruiting
        • Nottingham University Hospitals NHS Trust, Queens Medical Centre
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

  • 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:

    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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving etrasimod for ulcerative colitis
Drug: Etrasimod
As provided in real world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with symptomatic remission
Time Frame: Week 12
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Week 12
Proportion of patients with symptomatic remission
Time Frame: Week 52
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with clinical response
Time Frame: Week 12
Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Week 12
Proportion of patients with clinical response.
Time Frame: Week 52
Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Week 52
Proportion of corticosteroid-free patients with symptomatic remission
Time Frame: Week 52
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. Patients have to be corticosteroid-free for at least 12 weeks prior to the visit.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5041041
  • EFFECT-UC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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