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

NCT06838845 · AbbVie
In plain English

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Official title
Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China
About this study
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.
Eligibility 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
Study design
Enrollment target: 80 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-04-09
Estimated completion: 2026-12
Last updated: 2025-11-26
Primary outcomes
  • Achievement of clinical response per partial adapted Mayo score. (At Week 8)
Sponsor
AbbVie · industry
Contacts & investigators
ContactYuting Xie · contact · yuting.xie@abbvie.com
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (3)
The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997Recruiting
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753Recruiting
Guangzhou, Guangdong, China
The Second Affiliated Hospital Of Zhengzhou University /ID# 274754Recruiting
Zhengzhou, Henan, China