Study of Guselkumab and JAK Inhibitors for Treating Difficult Inflammatory Bowel Disease in Patients Aged 14 to 80

What this Trial Is About

This research aims to explore new treatment options for patients with refractory inflammatory bowel disease IBD who have not responded well to conventional biologics and small molecule drugs. These patients experience persistent active disease that significantly affects their quality of life and long-term health. The study focuses on evaluating the efficacy and safety of combining guselkumab GUS with JAK inhibitors, such as upadacitinib or tofacitinib, to provide novel therapeutic approaches for this challenging condition. Participants will receive treatment involving guselkumab along with JAK inhibitors like upadacitinib or tofacitinib. The study is observational, meaning researchers will monitor patients as they receive these treatments without assigning them randomly to groups or using placebos. The goal is to gather real-world data on how well this combination works and its safety profile in patients with difficult-to-treat IBD. During the study, researchers will assess patients clinical responses at 12 weeks and evaluate endoscopic responses at 52 weeks, measuring improvements in disease activity through specific clinical indices. Participants will be monitored for treatment outcomes and safety throughout the study duration. The lead sponsor is the Second Affiliated Hospital, School of Medicine, Zhejiang University, and the study is expected to continue until the end of 2028.

A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)