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

Last updated: December 17, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Etrasimod

Clinical Study ID

NCT06294925
C5041041
EFFECT-UC
  • Ages 18-65
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients ≥18 and <65 years of age at baseline

  • Patients with confirmed diagnosis of ulcerative colitis and who are prescribedetrasimod for moderately to severely active ulcerative colitis as per the productlabel independently of the decision to enroll a patient in this study.

  • Evidence of a personally signed and dated informed consent document indicating thatthe patient has been informed of all pertinent aspects of the study.

Exclusion

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 formedical or surgical intervention of any kind for UC (eg, colectomy) within 12weeks.

  2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3.Patients with a stoma or planned UC surgical intervention requiringhospitalization.

  3. Prior/Concomitant Therapy:

  4. any previous exposure to etrasimod including participation in the etrasimodclinical program.

  5. any co-medication with one of the following conventional therapies:methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) orwith any of the following advanced therapies for UC: biologics (a TNF, integrinor cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib orupadacitinib) or with any other S1P receptor modulator.

  • Not owning a digital device with internet connection and/or not willing to completehealth questionnaires on this device or not capable of using the healthquestionnaire collection tool.

  • Investigator site staff or Pfizer employees directly involved in the conduct of thestudy, site staff otherwise supervised by the investigator, and their respectivefamily.

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: Etrasimod
Phase:
Study Start date:
May 08, 2024
Estimated Completion Date:
May 13, 2027

Connect with a study center

  • Gastroenterologie OpernstraBe

    Kassel, Hessen 34117
    Germany

    Active - Recruiting

  • Praxis Heil und Müller

    Andernach, 56626
    Germany

    Active - Recruiting

  • MVZ für Gastroenterologie am Bayerischen Platz

    Berlin, 10825
    Germany

    Site Not Available

  • Alb-Donau Klinikum

    Blaubeuren, 89143
    Germany

    Site Not Available

  • MVZ Dachau

    Dachau, 85221
    Germany

    Active - Recruiting

  • Interdisziplinares Crohn Colitis Centrum

    Frankfurt am Main, 60594
    Germany

    Active - Recruiting

  • Facharztpraxis für Gastroenterologie

    Grevenbroich, 41515
    Germany

    Site Not Available

  • Studiengesellschaft BSF UG.

    Halle (Saale), 06108
    Germany

    Active - Recruiting

  • Praxis für Gasteroenterologie

    Heidelberg, 69115
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Kalk

    Koeln, 51103
    Germany

    Active - Recruiting

  • Praxis für Gasteroenterologie Lübeck

    Lübeck, 23560
    Germany

    Active - Recruiting

  • Klinikum Lüneburg

    Lüneburg, 21339
    Germany

    Site Not Available

  • Internistische Praxengemeinschaft Oldenburg

    Oldenburg, 10115
    Germany

    Active - Recruiting

  • Magen-Darm-Zentrum Remscheid

    Remscheid, 42859
    Germany

    Active - Recruiting

  • CED am Rhein

    Wesseling, 50389
    Germany

    Active - Recruiting

  • Royal Devon and Exeter NHS Foundation Trust.

    Exeter, Devon EX2 5DW
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow, Lanarkshire G4 0SF
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals NHS Trust, Queens Medical Centre

    Nottingham, Nottinghamshire NG7 2UH
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Active - Recruiting

  • Western General Hospital

    Edinburgh, Scotland EH4 2XU
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust Gastroenterology

    Cambridge, 351404
    United Kingdom

    Site Not Available

  • Northern Care Alliance NHS Foundation Trust, Greater Manchester

    Crumpsall, M8 5RB
    United Kingdom

    Active - Recruiting

  • University Hospitals Birmingham NHS Foundation Trust Gastroenterology

    Edgbaston, B15 2QD
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust, The Royal London Hospital

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS

    London, W2 1PG
    United Kingdom

    Active - Recruiting

  • St George's Hospital - St George's Healthcare Nhs Trust

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • St. Mark's Hospital

    London, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • University College London Hospital

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

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