A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
EFFECT-UC
Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC
2 other identifiers
observational
360
3 countries
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
May 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
March 30, 2026
March 1, 2026
2.1 years
February 28, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients with symptomatic remission
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
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 Outcomes (3)
Proportion of patients with clinical response
Week 12
Proportion of patients with clinical response.
Week 52
Proportion of corticosteroid-free patients with symptomatic remission
Week 52
Study Arms (1)
Patients receiving etrasimod for ulcerative colitis
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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 (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.
- \. 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (34)
Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9, Canada
Providence Health Care (PHC)
Vancouver, British Columbia, V6Z 2K5, Canada
London Health Sciences Centre
London, Ontario, N6A5A5, Canada
CHUM
Montreal, Quebec, H2X 3E4, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Gastroenterologie OpernstraBe
Kassel, Hesse, 34117, Germany
MVZ Gastroenterologie Aachen
Aachen, 52064, Germany
Praxis Heil und Müller
Andernach, 56626, Germany
MVZ für Gastroenterologie am Bayerischen Platz
Berlin, 10825, Germany
Evangelisches Krankenhaus Kalk
Cologne, 51103, Germany
MVZ Dachau
Dachau, 85221, Germany
Interdisziplinares Crohn Colitis Centrum
Frankfurt am Main, 60594, Germany
Facharztpraxis für Gastroenterologie
Grevenbroich, 41515, Germany
Studiengesellschaft BSF UG.
Halle, 06108, Germany
Praxis für Gasteroenterologie
Heidelberg, 69115, Germany
Praxis für Gasteroenterologie Lübeck
Lübeck, 23560, Germany
Klinikum Lüneburg
Lüneburg, 21339, Germany
Internistische Praxengemeinschaft Oldenburg
Oldenburg, 10115, Germany
Magen-Darm-Zentrum Remscheid
Remscheid, 42859, Germany
CED am Rhein
Wesseling, 50389, Germany
NHS Greater Glasgow and Clyde
Glasgow, Lanarkshire, G4 0SF, United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Northern Care Alliance NHS Foundation Trust, Greater Manchester
Crumpsall, M8 5RB, United Kingdom
Tunbridge Wells Hospital
Kent, TN2 4QJ, United Kingdom
Barts Health NHS Trust, The Royal London Hospital
London, E1 1BB, United Kingdom
St. Mark's Hospital
London, HA1 3UJ, United Kingdom
University College London Hospital
London, NW1 2PG, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Kings College Hospital
London, SE59RS, United Kingdom
St George's Hospital - St George's Healthcare Nhs Trust
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS
London, W2 1PG, United Kingdom
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Moran GW, Radford SJ, Walsh A, Battat R, McLean M, Kudela M, Binder E, Kulchytska N, Sahin B, Helwig U, Irving PM. Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis-EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol. BMJ Open. 2025 Dec 24;15(12):e106141. doi: 10.1136/bmjopen-2025-106141.
PMID: 41448713DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 6, 2024
Study Start
May 8, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.