Evaluating Upadacitinib for Ulcerative Colitis in Chinese Adults
Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China
This study is testing how well upadacitinib works and how safe it is for Chinese adults with moderate to severe ulcerative colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 3 sites (Guangzhou, Guangdong and 2 other locations) |
| Trial ID | NCT06838845 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and safety of upadacitinib in treating moderate to severely active ulcerative colitis (UC) among Chinese adult participants. Approximately 80 adults who have been prescribed upadacitinib by their physicians will be enrolled and followed for up to one year. The treatment will be administered according to local marketing authorization, and participants will attend regular visits for routine data collection without any additional burden compared to their standard care.
Who should consider this trial
Good fit: Ideal candidates include Chinese adults aged 18 and older diagnosed with moderate to severely active ulcerative colitis who have been prescribed upadacitinib.
Not a fit: Patients who are participating in other interventional trials or have contraindications to upadacitinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of upadacitinib for managing ulcerative colitis in the Chinese population.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating the effectiveness of upadacitinib for ulcerative colitis, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chinese participants meet the diagnosis of moderately to severely active Ulcerative colitis (UC) * Participants prescribed upadacitinib at discretion of their treating physicians based on sufficient consideration of benefits/risks for patients per local label * Participant must be an adult (≥ 18 years) * Participant must provide written authorization to use personal and/or health data prior to the entry into the study Exclusion Criteria: * Participant participating in any interventional trials * Participant with any contraindication to upadacitinib as listed on the local China label * Participant unwilling or unable to comply with the study requirements, including completion of patient reported outcome questionnaires
Where this trial is running
Guangzhou, Guangdong and 2 other locations
- The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997 — Guangzhou, Guangdong, China (Recruiting)
- The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753 — Guangzhou, Guangdong, China (Recruiting)
- The Second Affiliated Hospital Of Zhengzhou University /ID# 274754 — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Yuting Xie
- Email: yuting.xie@abbvie.com
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.