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

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 study follows patients who start guselkumab for moderate-to-severe inflammatory bowel disease to observe real-world use over time. It collects data from medical records to understand how long the drug remains in the body and how it is used outside of tightly controlled trials. The decision to treat is made by the physician, and participation requires informed consent. The study does not assign or modify treatment, but rather documents outcomes from routine care. Results may help clarify real-world persistence and patterns of guselkumab use in UC and CD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
* Must have confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
* Must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion criteria:

* Contraindicated to guselkumab per the label
* Is currently enrolled in an interventional clinical study
* Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included
* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
* Is unable to provide informed consent

Where it's running

• Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern
  Bern, Switzerland 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

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

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• Intestinal ultrasound-guided management for inflammatory bowel disease

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• Guselkumab in Breast Milk for Lactating Women on Guselkumab

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• Guselkumab in Ulcerative Colitis and Crohn’s Disease in Saudi Arabia: Real-World Use

  This study looks at how long people with moderate-to-severe Crohn’s disease or ulcerative colitis continue taking guselkumab in everyday clinical practice in Saudi Arabia.

  Recruiting Janssen Research & Development, LLC · Jeddah · NCT07541261

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.