Efficacy and Safety of Upadacitinib in Treating Inflammatory Bowel Disease A Multicenter, Observational Study in China

What this Trial Is About

Inflammatory Bowel Disease (IBD), which includes ulcerative colitis and Crohn's disease, has seen better patient outcomes with biologic treatments, but many patients do not respond well to these therapies. Upadacitinib is the only approved oral targeted drug for IBD in China, but there is limited research on its effectiveness and safety in Chinese patients. This study aims to observe how well upadacitinib works and how safe it is for treating Chinese patients with IBD, helping guide clinical decisions. Participants will receive upadacitinib as induction therapy: 45 mg once daily for 8 weeks if they have ulcerative colitis or 12 weeks for Crohn's disease. For maintenance therapy, the dose is usually 15 mg once daily, though patients with more severe or extensive disease may receive 30 mg once daily. This is a multicenter, single-arm, prospective, observational study conducted in real-world clinical settings. Throughout the study, researchers will monitor participants for clinical remission over 52 weeks. They will collect information on treatment effects and safety during this time. Participants must have a diagnosis of ulcerative colitis or Crohn's disease and be starting upadacitinib treatment. The study excludes those involved in other clinical trials or with contraindications to upadacitinib. The goal is to better understand upadacitinib's impact on Chinese patients with IBD.

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease