A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab

Recruiting now

Conditions studied: Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease

In brief

The purpose of this study is to evaluate how long guselkumab remains 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

NCT07532213

Run by

Janssen-Cilag A.G., Switzerland

People needed

50

Starts

2026-04-13

Expected to finish

2029-04-10

Last updated by the study team

2026-06-12

Who can join

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

You may qualify if…

• 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

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

• Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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