Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium

Study Identifier
P24-960
CT.gov Identifier
NCT06581042
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with a diagnosis of moderate to severe Crohn's disease or Ulcerative colitis, initiated with upadacitinib at least 12 months prior to inclusion, including participants that were initiated on upadacitinib, but later (i.e. at the moment of data collection) discontinued, or switched to another treatment. * Participants initiating commercially available upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study * Participants prescribed upadacitinib in accordance with the approved local label and treatment recommendations
    Exclusion Criteria:
    * Participants previously exposed to upadacitinib in a clinical trial or early access program * Participants participating in interventional research (not including non-interventional * Participants with stoma

    Protocol Summary

    Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).

    Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.

    Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice

    Study Locations

    Location
    Status
    Location
    Imelda Ziekenhuis /ID# 268631
    Bonheiden, Antwerpen, Belgium, 2820
    Status
    Recruiting
    Location
    Universite Libre de Bruxelles - Hopital Erasme /ID# 268632
    Anderlecht, Brussels Capital, Belgium, 1070
    Status
    Recruiting
    Location
    CHU de Liège /ID# 267209
    Liège, Liege, Belgium, 4000
    Status
    Recruiting
    Location
    UZ Gent /ID# 268630
    Ghent, Oost-Vlaanderen, Belgium, 9000
    Status
    Recruiting
    Location
    Vitaz /Id# 268637
    Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    Status
    Recruiting
    Location
    AZ Groeninge /ID# 268638
    Kortrijk, West-Vlaanderen, Belgium, 8500
    Status
    Recruiting
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