Evaluating Upadacitinib and Risankizumab as Second-Line Treatments for Moderate-to-Severe Crohns Disease in Adults in Everyday Clinical Practice

What this Trial Is About

This research focuses on adults with moderate-to-severe Crohns Disease CD, a chronic inflammatory condition of the digestive tract. It aims to evaluate how effective two approved drugs, upadacitinib and risankizumab, are as second-line treatments for CD in real-world clinical settings. Approximately 250 participants prescribed either drug by their physicians will be enrolled across 25 sites in Italy. Participants will receive either upadacitinib or risankizumab as part of their usual medical care, following local prescribing guidelines. The study includes a retrospective phase looking back up to 2 years before enrollment and a prospective phase where participants will be observed for up to 18 months after starting the medication. Both groups will be followed from their first dose throughout the study period. During this time, participants will not experience any additional study-related burden beyond their routine care. Researchers will review clinical records and monitor outcomes such as the percentage of participants achieving corticosteroid-free remission at 12 months. The study aims to gather real-world data on these treatments effectiveness and safety over time, with no extra visits or procedures required beyond standard practice.

A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting