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

Official title

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

Overview

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.

Interventions

• Drug Etrasimod
  As provided in real world practice

Primary outcome measures

• Proportion of patients with symptomatic remission [Time frame: Week 12]
• Proportion of patients with symptomatic remission [Time frame: Week 52]

Secondary outcome measures (3)

• Proportion of patients with clinical response [Time frame: Week 12]
• Proportion of patients with clinical response. [Time frame: Week 52]
• Proportion of corticosteroid-free patients with symptomatic remission [Time frame: Week 52]

Eligibility criteria

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:

• 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:

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• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 15 centers

• Gastroenterologie OpernstraBe — Kassel
• MVZ Gastroenterologie Aachen — Aachen
• Praxis Heil und Müller — Andernach
• MVZ für Gastroenterologie am Bayerischen Platz — Berlin
• Evangelisches Krankenhaus Kalk — Cologne
• MVZ Dachau — Dachau
• Interdisziplinares Crohn Colitis Centrum — Frankfurt am Main
• Facharztpraxis für Gastroenterologie — Grevenbroich
• … and 7 more centers

United Kingdom · 14 centers

• NHS Greater Glasgow and Clyde — Glasgow
• Nottingham University Hospitals NHS Trust, Queens Medical Centre — Nottingham
• Oxford University Hospitals NHS Foundation Trust — Oxford
• Western General Hospital — Edinburgh
• Northern Care Alliance NHS Foundation Trust, Greater Manchester — Crumpsall
• Tunbridge Wells Hospital — Kent
• Barts Health NHS Trust, The Royal London Hospital — London
• St. Mark's Hospital — London
• … and 6 more centers

Canada · 9 centers

• Kelowna Gastroenterology Associates — Kelowna
• Vancouver Coastal Health — Vancouver
• Vancouver Coastal Health — Vancouver
• Providence Health Care (PHC) — Vancouver
• London Health Sciences Centre — London
• Ottawa Hospital — Ottawa
• CHUM — Montreal
• Montreal General Hospital — Montreal
• … and 1 more center

Publications

• 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 41448713

Identifiers

NCT: NCT06294925 · C5041041 · EFFECT-UC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗