RecruitingNCT06838845

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


Sponsor

AbbVie

Enrollment

80 participants

Start Date

Apr 9, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational study (no experimental treatment) tracking how well a drug called upadacitinib works in real-world Chinese patients with moderate to severe ulcerative colitis (a chronic inflammatory bowel disease). Doctors are already prescribing this approved medication; the study just collects data on outcomes and safety. **You may be eligible if...** - You are 18 or older and have moderate to severe ulcerative colitis - Your doctor has already decided to prescribe upadacitinib for you - You are willing to provide consent for your health data to be used - You are being treated in China **You may NOT be eligible if...** - You are participating in another interventional clinical trial - You have a medical reason your doctor says you should not take upadacitinib - You are unwilling or unable to follow the study requirements, including filling out questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06838845


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