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:
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Presence of clinical findings suggestive of Crohn's disease.
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Severe extensive colitis evidenced by:
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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.
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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:
- 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.
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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.
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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.
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