Follows Chinese patients with inflammatory bowel disease taking upadacitinib
Observes how upadacitinib, a pill, works and affects people with Crohn's or colitis.
Key facts
- Who runs it
- Xiang Gao
- Where
- Guangzhou, Liuzhou, Meizhou, Nanning, and Shenzhen, ChinaSee the 6 sites
- Trial code
- Registry title
- Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
- Status
- Recruiting
- People taking part
- 174 people, planned
- Started
- 1 Jan 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Upadacitinib
- Record updated
- 17 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with ulcerative colitis or Crohn's disease whose doctor decides they need to start upadacitinib.
- Sex
- People of any gender can join.
- Disease stage
- Ulcerative colitis or Crohn's disease, diagnosed according to current guidelines.
- Earlier treatment
- The doctor must judge that the person needs to start upadacitinib for the first time.
Main reasons for not taking part
- Taking part in, or planning to take part in, another clinical study
- Having a reason that rules out upadacitinib, as stated in the drug's instructions
- Being judged unsuitable for the study by the researchers
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in China
- Sixth Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Xiang GaoTaking people
- The Second Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou, ChinaContact: Haiyan, ZhangTaking people
- Liuzhou People's HospitalLiuzhou, ChinaContact: Yun HeTaking people
- Meizhou People's HospitalMeizhou, ChinaContact: Taofeng JiangTaking people
- Ruikang Hospital Affiliated to Guangxi University of Chinese MedicineNanning, ChinaContact: Tao ZhangTaking people
- The Eighth Affiliated Hospital, Sun Yat-Sen UniversityShenzhen, ChinaContact: Xiaoling WangTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Crohn's disease
Treatment: Upadacitinib
- ulcerative colitis
Treatment: Upadacitinib
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Follows Chinese patients with inflammatory bowel disease taking upadacitinibGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 January 2025