Clinical trial NCT06581042: Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium
Official title: Understanding Local TReatment Patterns and Outcomes With upAdacitinib in IBD Patients in Belgium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Ulcerative colitis
Crohn's disease
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with ulcerative colitis or Crohn's Disease

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


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

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis
timeFrame: Up to approximately 52 weeks
measure: Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease
timeFrame: Up to approximately 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis /ID# 268631
state: Antwerpen
city: Anderlecht
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme /ID# 268632
state: Bruxelles-Capitale
city: Liège
country: Belgium
facility: CHU de Liège /ID# 267209
state: Liege
city: Gent
country: Belgium
facility: UZ Gent /ID# 268630
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 268637
state: Oost-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 268638
state: West-Vlaanderen
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 268662
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: