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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997, Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Achievement of clinical response per partial adapted Mayo score.

Time frame: At Week 8

Defined as a decrease in Partial Adapted Mayo score of ≥ 1 point and a decrease of ≥ 30% from Baseline, PLUS either a decrease in rectal bleeding sub-score (RBS) of ≥ 1 point or an absolute RBS of ≤ 1.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuting Xie

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Feb 21, 2025
Registry last updated: Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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