RecruitingNCT07302360

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

Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study

Sponsor

Xian-Janssen Pharmaceutical Ltd.

Enrollment

200 participants

Start Date

Dec 11, 2025

Study Type

OBSERVATIONAL

Conditions

Colitis Ulcerative

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study is tracking Chinese patients with moderate-to-severe ulcerative colitis (UC) who are starting treatment with guselkumab, a biologic medication. Researchers want to see how well guselkumab works in everyday clinical practice outside of a controlled trial setting. **You may be eligible if...** - You have been diagnosed with moderately to severely active ulcerative colitis, confirmed by endoscopy (camera exam of the colon) - Your doctor has decided to start you on guselkumab as part of your regular care - You have not previously used advanced biologic or small-molecule therapies for UC (treatment-naive) **You may NOT be eligible if...** - You have already used biologics or other advanced therapies for UC - Your UC is mild or in remission - You have conditions that would make guselkumab unsafe for you 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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