NCT06780683 Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
| NCT ID | NCT06780683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiang Gao |
| Condition | Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 174 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 174 participants in total. It began in 2024-01-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06780683 clinical trial?
This trial is open to participants of all sexes, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780683 currently recruiting?
Yes, NCT06780683 is actively recruiting participants. Contact the research team at linlang3@mail.sysu.edu.cn for enrollment information.
Where is the NCT06780683 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Meizhou, China, Shenzhen, China and 2 additional locations.
Who is sponsoring the NCT06780683 clinical trial?
NCT06780683 is sponsored by Xiang Gao. The trial plans to enroll 174 participants.