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Effectiveness of Etrasimod for Ulcerative Colitis

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

Observational Pfizer · NCT06294925

This study is testing if etrasimod can help adults with moderate to severe ulcerative colitis feel better when it's chosen as their treatment.

Quick facts

Study typeObservational
Enrollment360 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsfilgotinib, tofacitinib, upadacitinib, methotrexate
Locations34 sites (Vancouver, British Columbia and 33 other locations)
Trial IDNCT06294925 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of etrasimod in patients with moderate to severe ulcerative colitis. Participants will be treated according to standard care, with inclusion based on the treating physician's decision that etrasimod is the best treatment option. Patients aged 18 to 65 who have not previously taken etrasimod will complete health questionnaires online throughout the 52-week study period. Safety follow-up will occur 28 days after the treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of moderate to severe ulcerative colitis who are prescribed etrasimod.

Not a fit: Patients with Crohn's disease, severe extensive colitis, or those requiring surgical intervention for ulcerative colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of etrasimod for managing ulcerative colitis symptoms.

How similar studies have performed: Other studies have shown promise with S1P modulators like etrasimod, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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:

  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.

Where this trial is running

Vancouver, British Columbia and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colitis, Ulcerativepatient related outcomesreal world dataS1P modulatorSymptomatic RemissionCorticosteroid free symptomatic remission
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.