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NCT06838845Recruiting

An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)

Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China

Source: ClinicalTrials.gov · Last updated 26 Nov 2025

Brief summary (registry, in English)

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 study will assess how effective upadacitinib is in treating UC within a Chinese population. Upadacitinib is an approved drug for treating UC. Approximately 80 adult participants, who have been prescribed upadacitinib for UC by their physician in accordance with local label, will be enrolled in China. Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 1 year. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
17 Feb 2025
Start date
9 Apr 2025
Primary completion date
Dec 2026
Lead sponsor
AbbVie
NCT number
NCT06838845

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 9 Apr 2025 to the primary completion date, Dec 2026
  • 3 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.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The Second Affiliated Hospital Of Zhengzhou University /ID# 274754
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.