Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium
Observational · No treatment assigned · 11 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis and Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 280 participants are expected to take part.
- Start date: 2024-09-27.
- Main results expected around 2029-09 (estimate from the record).
- 11 study sites listed (11 marked recruiting) in Belgium.
Main thing being measured
- Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis (Up to approximately 52 weeks)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis; Crohn's Disease |
| Lead sponsor | AbbVie |
| Enrollment | 280 (estimated) |
| Start date | 2024-09-27 |
| Primary completion (est.) | 2029-09 |
| First posted | 2024-08-30 |
| Last updated | 2026-09-23 |
| Official title | Understanding Local TReatment Patterns and Outcomes With upAdacitinib in IBD Patients in Belgium |
| ClinicalTrials.gov ID | NCT06581042 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (11)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Liege /ID# 267209 | Liège | Belgium | Recruiting |
| Imelda Ziekenhuis /ID# 268631 | Bonheiden, Antwerpen | Belgium | Recruiting |
| Universite Libre de Bruxelles - Hopital Erasme /ID# 268632 | Anderlecht, Brussels Capital | Belgium | Recruiting |
| Chu De Charleroi - Hopital Civil Marie Curie /ID# 284063 | Lodelinsart, Hainaut | Belgium | Recruiting |
| Centre Hospitalier De Wallonie Picarde - Site Notre Dame /ID# 284064 | Tournai, Hainaut | Belgium | Recruiting |
| Groupe Sante CHC - Clinique du MontLegia /ID# 268662 | Liège, Liege | Belgium | Recruiting |
| Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 283334 | Genk, Limburg | 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 |
| AZ-Delta. /ID# 283323 | Roeselare, West-Vlaanderen | Belgium | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.