A Multi-Center Prospective Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ulcerative Colitis
  • Age: Between 18 Year(s) - 65 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Age =18 years and < 65 years at baseline
    2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC as per the FDA approved USPI
    3. Evidence of a personally signed and dated ICD indicating that the patient has been informed of all pertinent aspects of the study

You may not be eligible for this study if the following are true:

    1. The presence of clinical findings suggestive of Crohn’s disease
    2. Severe extensive colitis evidenced by:
      • 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:
      • 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)
      • Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi [filgotinib, tofacitinib, or upadacitinib]) or with any other S1P receptor modulator
    5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
    6. 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



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