Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Sponsor: Xiang Gao

View on ClinicalTrials.gov

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

DRUG

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