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

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 with moderate-to-severe Crohn’s disease or ulcerative colitis who start guselkumab in Saudi Arabia to see how long they remain on the treatment in a real-world setting. It uses data from routine care to describe treatment persistence and patterns after initiation. Participation depends on physician prescribing decisions and patient consent, and excludes those already in interventional trials or with prior exposure to IL-23 inhibitors. The study does not specify a formal interventional protocol or comparative arm. Results could inform real-world use of guselkumab in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent
* The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
* The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification

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

• Al Salama Hospital
  Jeddah, Saudi Arabia Recruiting

Study contacts

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

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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.