Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study

What this Trial Is About

This research aims to evaluate the effectiveness and safety of upadacitinib, an oral small molecule drug approved for inflammatory bowel disease (IBD) in China, specifically in patients with ulcerative colitis (UC) and Crohn's disease (CD). Despite improvements in IBD treatment with biologic therapies, many patients do not respond well to existing options, and there is limited data on upadacitinib's performance in the Chinese population. The study will provide real-world evidence to support clinical decisions for treating IBD in this group. Participants will receive upadacitinib as part of their treatment, with an induction phase of 45 mg once daily for 8 weeks for UC or 12 weeks for CD. Following induction, maintenance therapy consists of 15 mg once daily, with the option to increase to 30 mg daily for those with more severe or extensive disease. This is a multicenter, single-arm, prospective observational study designed to monitor patients under usual clinical care rather than assigning treatments randomly. During the study, researchers will observe and record patients' responses to upadacitinib over time, focusing on the clinical remission rate at 52 weeks as the primary outcome. Safety and effectiveness will be assessed through regular follow-ups and clinical evaluations. The study's duration and detailed data collection will help understand how well upadacitinib works and how safe it is for Chinese patients living with IBD, including both UC and CD.

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease