Follows Chinese patients with inflammatory bowel disease taking upadacitinib
Observes how upadacitinib, a pill, works and affects people with Crohn's or colitis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
Key facts
- Where
- Guangzhou, Liuzhou, Meizhou, Nanning, and Shenzhen, ChinaSee the 6 sites
Where in China
- Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- The Second Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou, ChinaTaking people
- Liuzhou People's HospitalLiuzhou, ChinaTaking people
- Meizhou People's HospitalMeizhou, ChinaTaking people
- Ruikang Hospital Affiliated to Guangxi University of Chinese MedicineNanning, ChinaTaking people
- The Eighth Affiliated Hospital, Sun Yat-Sen UniversityShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xiang Gao
- Trial code
- NCT06780683
- Record updated
- 17 January 2025
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study
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.
Inclusion: 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: 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.