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Recruiting NCT07302360

A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis

Trial Parameters

Condition Colitis, Ulcerative
Sponsor Xian-Janssen Pharmaceutical Ltd.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-15
Completion 2028-06-30

Brief Summary

The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Eligibility Criteria

Inclusion criteria: * Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\>=) 2; c) Mayo rectal bleeding subscore (RBS) \>= 1 at baseline * Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert * Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment * Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements Exclusion criteria: * Acute severe UC or i

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