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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Colitis
    Ulcerative

NCT07302360

Xian-Janssen Pharmaceutical Ltd.

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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