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

Recruiting

• Conditions: Ulcerative Colitis; Crohn's Disease

• Registration Number: NCT06581042
• Lead Sponsor: AbbVie

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Study Start: 2024-09-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2029-09
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis	Up to approximately 52 weeks	Clinical remission is defined as: stool frequency (SF) score \< = 1 and not greater than baseline and Rectal bleeding (RB) score = 0
Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease	Up to approximately 52 weeks	Clinical remission is defined as stool frequency (SF) score \< =3 and not worse than baseline and Abdominal Pain (AP) score \< =1 and not worse than baseline

Trial Locations

Locations (7)

Imelda Ziekenhuis /ID# 268631; 🇧🇪 Bonheiden, Antwerpen, Belgium

CHU de Liège /ID# 267209; 🇧🇪 Liège, Liege, Belgium

UZ Gent /ID# 268630; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

AZ Groeninge /ID# 268638; 🇧🇪 Kortrijk, West-Vlaanderen, Belgium

Universite Libre de Bruxelles - Hopital Erasme /ID# 268632; 🇧🇪 Anderlecht, Bruxelles-Capitale, Belgium

Vitaz /Id# 268637; 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

Groupe Sante CHC - Clinique du MontLegia /ID# 268662; 🇧🇪 Liege, Belgium