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Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
Sponsor: Xiang Gao
Summary
Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.
Official title: Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
174
Start Date
2024-01-01
Completion Date
2028-12-31
Last Updated
2025-01-17
Healthy Volunteers
No
Interventions
Upadacitinib
Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease). Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.
Locations (6)
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, Guangxi, China