Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult participants with ulcerative colitis or Crohn's Disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
280 Participants
are grouped into 1 trial groupGroup A: Upadacitinib
Trial outcomes
Primary outcomes
1
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
Time frame
Up to approximately 52 weeks2
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
Time frame
Up to approximately 52 weeks Source ClinicalTrials.gov