Assessing Upadacitinib Treatment in Adults with Inflammatory Bowel Disease in Belgium

Understanding Local TReatment Patterns and Outcomes With upAdacitinib in IBD Patients in Belgium

This study is testing how well the medication upadacitinib works and how safe it is for adults with moderate to severe ulcerative colitis and Crohn's disease in Belgium over three years.

Quick facts

• Study type: Observational
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (industry)
• Drugs / interventions: upadacitinib
• Locations: 7 sites (Bonheiden, Antwerpen and 6 other locations)
• Trial ID: NCT06581042 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the long-term effectiveness and safety of upadacitinib in adult patients with moderate to severe ulcerative colitis and Crohn's disease in Belgium. Approximately 280 participants will be enrolled from 8 sites, receiving upadacitinib as prescribed by their physicians in routine clinical practice. Participants will be monitored for up to 3 years to gather data on treatment outcomes without any additional burden from the study.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with moderate to severe Crohn's disease or ulcerative colitis who have been prescribed upadacitinib at least 12 months prior to inclusion.

Not a fit: Patients who have previously participated in clinical trials involving upadacitinib or those with a stoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of upadacitinib for managing inflammatory bowel diseases.

How similar studies have performed: Other studies have shown positive outcomes with upadacitinib in treating inflammatory bowel diseases, indicating that this approach is supported by existing evidence.

Eligibility 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

Where this trial is running

Bonheiden, Antwerpen and 6 other locations

• Imelda Ziekenhuis /ID# 268631 — Bonheiden, Antwerpen, Belgium (RECRUITING)
• Universite Libre de Bruxelles - Hopital Erasme /ID# 268632 — Anderlecht, Brussels Capital, Belgium (RECRUITING)
• CHU de Liège /ID# 267209 — Liège, Liege, Belgium (RECRUITING)
• UZ Gent /ID# 268630 — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)
• Vitaz /Id# 268637 — Sint-Niklaas, Oost-Vlaanderen, Belgium (RECRUITING)
• AZ Groeninge /ID# 268638 — Kortrijk, West-Vlaanderen, Belgium (RECRUITING)
• Groupe Sante CHC - Clinique du MontLegia /ID# 268662 — Liège, Belgium (RECRUITING)

Study contacts

• Study coordinator: Liesbeth Ghys

Conditions: Ulcerative Colitis, Crohn's Disease, Ulcerative colitis, Crohn's disease, Upadacitinib, RINVOQ