Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
Recruiting · NCT06780683 · Observational (researchers observe without assigning treatment) · Lead sponsor: Xiang Gao
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.
Where it is running
12 locations listed.
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine - Guangzhou, Guangdong, China
- Sixth Affiliated Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- 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
- Meizhou People's Hospital - Meizhou, Guangdong, China
- The Eighth Affiliated Hospital, Sun Yat-Sen University - Shenzhen, Guangdong, China
- The Eighth Affiliated Hospital, Sun Yat-Sen University - Shenzhen, Guangdong, China
- Liuzhou People's Hospital - Liuzhou, Guangxi, China
- Liuzhou People's Hospital - Liuzhou, Guangxi, China
- Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine - Nanning, Guangxi, China
- Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine - Nanning, Guangxi, China