Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: a Multicenter, Single-Arm, Prospective, Observational Real-World Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.

Locations
Other Locations
China
Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
RECRUITING
Guangzhou
Liuzhou People's Hospital
RECRUITING
Liuzhou
Meizhou People's Hospital
RECRUITING
Meizhou
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
RECRUITING
Nanning
The Eighth Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Shenzhen
Contact Information
Primary
Lang Lin
linlang3@mail.sysu.edu.cn
+86-020-38663423
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 174
Treatments
Crohn's disease
ulcerative colitis
Sponsors
Leads: Xiang Gao

This content was sourced from clinicaltrials.gov