Study Contact

CONTACT

Lead Sponsor

Janssen Research & Development, LLC

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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

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