Guselkumab for Chinese patients with moderate-to-severe ulcerative colitis in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, real-world study follows biologic‑naive Chinese participants with moderate-to-severe ulcerative colitis who start guselkumab as part of routine care. Eligible participants have a modified Mayo score of 4–9, endoscopic Mayo subscore ≥2, and rectal bleeding subscore ≥1 at baseline, and they initiate treatment per their physician's decision. Clinical outcomes, endoscopic findings, patient-reported function and quality-of-life measures, and routine safety data will be collected from medical records and clinic visits. The study aims to characterize the effectiveness and tolerability of guselkumab in everyday clinical practice in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting
• Peking University People's Hospital
  Beijing, China Recruiting
• Changzhou No 2 Peoples Hospital
  Changzhou, China Recruiting
• The First Affiliated Hospital Sun Yat-Sen University
  Guangzhou, China Recruiting
• The Sixth Affiliated Hospital of Sun Yat-sen University
  Guangzhou, China Recruiting
• The Second Affiliated Hospital of Zhejiang University
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guselkumab use in Crohn's disease and ulcerative colitis

  This study looks at how long people with moderate-to-severe Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen-Cilag Pharma GmbH · Vienna · NCT07606339

• Real-world use of guselkumab in Crohn’s disease and ulcerative colitis

  This study tests how long guselkumab stays in the bodies of adults with moderate-to-severe Crohn’s disease or ulcerative colitis treated in real-world clinical settings.

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• Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK

  This project will see how well guselkumab works for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting the treatment in routine UK care.

  Recruiting Janssen-Cilag Ltd. · Harrow · NCT07242248

• Guselkumab treatment for Crohn's disease and ulcerative colitis in Germany

  This project will try to see how well guselkumab works and how it affects symptoms, quality of life, and daily activities for adults with Crohn's disease or ulcerative colitis receiving routine care in Germany.

  Recruiting Janssen-Cilag G.m.b.H · Berlin · NCT07102368

• Long-term evaluation of guselkumab for children with inflammatory bowel disease and juvenile arthritis

  This study tests how safe and effective the medication guselkumab is for children with inflammatory bowel disease or juvenile arthritis over a long period of time.

  Recruiting at 53 sites Phase 3 Janssen Research & Development, LLC · Atlanta, Georgia and 52 other locations · NCT06663332

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

  This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.

  Recruiting Janssen Research & Development, LLC · Amiens · NCT07822529

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.