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

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT06838845
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Status Verified: 2025-04
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of clinical response per partial adapted Mayo score.	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.

Trial Locations

Locations (3)

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

The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753; 🇨🇳 Guangzhou, Guangdong, China

The Second Affiliated Hospital Of Zhengzhou University /ID# 274754; 🇨🇳 Zhengzhou, Henan, China