NCT06780683Recruiting
Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study
Source: ClinicalTrials.gov · Last updated 17 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 174 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Xiang Gao
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06780683
What you commit to
- Study type: Observational
- Planned participants: 174
- From 1 Jan 2024 to the primary completion date, 31 Dec 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou University of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Recruiting |
| Meizhou People's Hospital Coordinator of this site? Confirm its status | Meizhou | China | Recruiting |
| Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| The Eighth Affiliated Hospital, Sun Yat-Sen University Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.