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

NCT07302360 · Xian-Janssen Pharmaceutical Ltd.
In plain English

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Official title
Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study
About this study
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 infectious colitis or other conditions when patients is likely to require a colectomy * Contraindicated to guselkumab per the label * Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab * Participants who will be receiving guselkumab therapy combined with a second advanced therapy * Participants with a history of colectomy and/or pouch
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-12-15
Estimated completion: 2028-06-30
Last updated: 2026-04-13
Primary outcomes
  • Percentage of Participants Achieving Clinical Response at Week 12 (At Week 12)
Sponsor
Xian-Janssen Pharmaceutical Ltd. · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorXian-Janssen Pharmaceutical Ltd., China Clinical Trial · study_director, Xian-Janssen Pharmaceutical Ltd.
All locations (1)
The Second Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, China
A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · TrialPath