Evaluating Upadacitinib for 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
Sixth Affiliated Hospital, Sun Yat-sen University · NCT06780683
This study is testing how well the oral medication Upadacitinib works for people in China with Inflammatory Bowel Disease who haven't responded to other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 174 (estimated) |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University (other) |
| Drugs / interventions | upadacitinib |
| Locations | 6 sites (Guangzhou, Guangdong and 5 other locations) |
| Trial ID | NCT06780683 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the efficacy and safety of Upadacitinib in treating patients with Inflammatory Bowel Disease (IBD), specifically Crohn's Disease and Ulcerative Colitis, in China. It aims to gather real-world data from multiple centers to assess how well this oral medication works for patients who are either primary or secondary non-responders to existing biologic treatments. By analyzing the outcomes of patients requiring Upadacitinib, the study seeks to provide valuable insights for clinical decision-making in the management of IBD.
Who should consider this trial
Good fit: Ideal candidates include patients of any gender diagnosed with ulcerative colitis or Crohn's disease who require initial treatment with Upadacitinib.
Not a fit: Patients currently participating in other clinical studies or those with contraindications to Upadacitinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with Inflammatory Bowel Disease in China.
How similar studies have performed: While there is limited research on Upadacitinib specifically in the Chinese IBD population, other studies have shown positive outcomes with similar biologic treatments in IBD.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 5 other locations
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (RECRUITING)
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
- Meizhou People's Hospital — Meizhou, Guangdong, China (RECRUITING)
- The Eighth Affiliated Hospital, Sun Yat-Sen University — Shenzhen, Guangdong, China (RECRUITING)
- Liuzhou People's Hospital — Liuzhou, Guangxi, China (RECRUITING)
- Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine — Nanning, Guangxi, China (RECRUITING)
Study contacts
- Study coordinator: Lang Lin
- Email: linlang3@mail.sysu.edu.cn
- Phone: +86-020-38663423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis