Real-World Study of Guselkumab Treatment in Chinese Adults with Moderate to Severe Ulcerative Colitis Who Have Not Received Biologic Therapy

What this Trial Is About

Researchers are evaluating the effects of guselkumab in Chinese adults with moderate-to-severe ulcerative colitis UC who have not previously received biologic therapy. This observational study aims to measure changes in health, function, and quality of life among these patients in real-world clinical practice. The study is sponsored by Xian-Janssen Pharmaceutical Ltd. and focuses on patients starting guselkumab treatment as part of their routine care. Participants with confirmed moderate-to-severe UC will be treated with guselkumab according to standard clinical practice, without receiving the drug from the study itself. The study collects and observes data from medical records and clinical visits. Researchers will monitor outcomes such as clinical response, symptomatic response, remission rates, endoscopic improvements, dosing schedules, and biomarker changes over a period extending up to 48 weeks. During the study, participants will follow their usual treatment and attend clinical visits where data on symptoms, stool frequency, bleeding, inflammatory markers, and quality of life will be collected. The main outcome is the percentage of participants achieving clinical response at Week 12, with additional assessments at Weeks 2, 24, and 48. Researchers will also track treatment discontinuation, dose changes, and other clinical indicators to understand guselkumabs effects in everyday medical practice.

A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis