A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia

Recruiting now

Conditions studied: Colitis, Ulcerative, Crohn Disease

In brief

The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.

Key facts

Study ID

NCT07541261

Run by

Janssen Research & Development, LLC

People needed

100

Starts

2026-05-12

Expected to finish

2029-01-29

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Al Salama Hospital — Jeddah, Saudi Arabia (enrolling)

Full record on ClinicalTrials.gov

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