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

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

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 Overview

• Status: Recruiting
• Conditions: Crohn's Disease; Ulcerative Colitis

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Liesbeth Ghys; Phone Number: 844-663-3742; Email: liesbeth.ghys@abbvie.com

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Recruiting
    • Groupe Sante CHC - Clinique du MontLegia /ID# 268662
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Recruiting
      • Imelda Ziekenhuis /ID# 268631
  • Bruxelles-Capitale
    • Anderlecht, Bruxelles-Capitale, Belgium, 1070
      • Recruiting
      • Universite Libre de Bruxelles - Hopital Erasme /ID# 268632
  • Liege
    • Liège, Liege, Belgium, 4000
      • Recruiting
      • CHU de Liège /ID# 267209
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Gent /ID# 268630
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Recruiting
      • Vitaz /Id# 268637
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Recruiting
      • AZ Groeninge /ID# 268638

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with ulcerative colitis or Crohn's Disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Upadacitinib; Participants will receive upadacitinib as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Upadacitinib; Crohn's disease; Ulcerative colitis; RINVOQ
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: P24-960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No