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Clinical Trials in Belgium / NCT06581042
Recruiting Observational

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

NCT06581042 · tracked via the Priya Life Science Belgium tracker
Sponsor
AbbVie
Phase
Observational
Started
2024-09-27
Last updated
2026-09-23

Condition(s) studied

Ulcerative ColitisCrohn's Disease

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (11)

FacilityCityRegionStatus
Imelda Ziekenhuis /ID# 268631 Bonheiden Antwerpen Recruiting
Universite Libre de Bruxelles - Hopital Erasme /ID# 268632 Anderlecht Brussels Capital Recruiting
Chu De Charleroi - Hopital Civil Marie Curie /ID# 284063 Lodelinsart Hainaut Recruiting
Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 284064 Tournai Hainaut Recruiting
Groupe Sante CHC - Clinique du MontLegia /ID# 268662 Liège Liege Recruiting
Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 283334 Genk Limburg Recruiting
UZ Gent /ID# 268630 Ghent Oost-Vlaanderen Recruiting
Vitaz /Id# 268637 Sint-Niklaas Oost-Vlaanderen Recruiting
AZ Groeninge /ID# 268638 Kortrijk West-Vlaanderen Recruiting
AZ-Delta. /ID# 283323 Roeselare West-Vlaanderen Recruiting
CHU de Liege /ID# 267209 Liège Belgium Recruiting

More AbbVie trials in Belgium

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Active, not recruiting
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease Active, not recruiting
A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo Active, not recruiting
A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata Recruiting
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine Recruiting

Other trials for the same condition

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease Active, not recruiting
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06581042 on ClinicalTrials.gov ↗ ← All trials in Belgium