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

Last updated: March 3, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Ulcers

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT06581042
P24-960
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with a diagnosis of moderate to severe Crohn's disease or Ulcerativecolitis, initiated with upadacitinib at least 12 months prior to inclusion,including participants that were initiated on upadacitinib, but later (i.e. at themoment of data collection) discontinued, or switched to another treatment.

  • Participants initiating commercially available upadacitinib at the clinician'sdiscretion as part of their routine clinical care; the decision to administerupadacitinib must be made prior to and independent of recruitment into the study

  • Participants prescribed upadacitinib in accordance with the approved local label andtreatment recommendations

Exclusion

Exclusion Criteria:

  • Participants previously exposed to upadacitinib in a clinical trial or early accessprogram

  • Participants participating in interventional research (not includingnon-interventional

  • Participants with stoma

Study Design

Total Participants: 280
Study Start date:
September 27, 2024
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • Imelda Ziekenhuis /ID# 268631

    Bonheiden, Antwerpen 2820
    Belgium

    Active - Recruiting

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 268632

    Anderlecht, Bruxelles-Capitale 1070
    Belgium

    Active - Recruiting

  • CHU de Liège /ID# 267209

    Liège, Liege 4000
    Belgium

    Active - Recruiting

  • UZ Gent /ID# 268630

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • Vitaz /Id# 268637

    Sint-Niklaas, Oost-Vlaanderen 9100
    Belgium

    Active - Recruiting

  • AZ Groeninge /ID# 268638

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Active - Recruiting

  • Groupe Sante CHC - Clinique du MontLegia /ID# 268662

    Liege, 4000
    Belgium

    Active - Recruiting

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