Status:

RECRUITING

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

Lead Sponsor:

Pfizer

Conditions:

Colitis, Ulcerative

Eligibility:

All Genders

18-64 years

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 accor...

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:

    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.

Key Trial Info

Start Date :

May 8 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT06294925

Start Date

May 8 2024

End Date

June 30 2026

Last Update

March 30 2026

Active Locations (34)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (34 locations)

1

Vancouver Coastal Health

Vancouver, British Columbia, Canada, V5Z 1M9

2

Providence Health Care (PHC)

Vancouver, British Columbia, Canada, V6Z 2K5

3

London Health Sciences Centre

London, Ontario, Canada, N6A5A5

4

CHUM

Montreal, Quebec, Canada, H2X 3E4

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