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

Launched by ABBVIE · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called upadacitinib for adults with moderate to severe inflammatory bowel diseases, specifically ulcerative colitis and Crohn's disease. The goal is to see how well this medication works in real-life situations, as it has already been approved for these conditions. About 280 participants across 8 sites in Belgium will be involved. They will receive upadacitinib as prescribed by their doctors and will be monitored for up to 3 years to gather information on their treatment outcomes.

To be eligible for this trial, participants need to have been diagnosed with moderate to severe Crohn's disease or ulcerative colitis and started on upadacitinib at least 12 months before joining the study. They should also be receiving the medication as part of their regular medical care. Participants can expect to attend regular check-ups at their hospital or clinic, but there should not be any extra demands on their time beyond their usual visits. Importantly, this trial does not require participants to make any changes to their current treatment plan unless their doctor decides otherwise.

Gender

ALL

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