An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)
Observational · No treatment assigned · 3 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 1 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-04-09.
- Main results expected around 2026-12 (estimate from the record).
- 3 study sites listed (3 marked recruiting) in China.
Main thing being measured
- Achievement of clinical response per partial adapted Mayo score. (At Week 8)
In the researchers’ words
Ulcerative colitis (UC) is a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus..
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | AbbVie |
| Enrollment | 80 (estimated) |
| Start date | 2025-04-09 |
| Primary completion (est.) | 2026-12 |
| First posted | 2025-02-21 |
| Last updated | 2025-11-26 |
| Official title | Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China |
| ClinicalTrials.gov ID | NCT06838845 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.