A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

Starting soon

Conditions studied: Crohn Disease, Colitis, Ulcerative

In brief

The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.

Key facts

Study ID: NCT07746765
Run by: Janssen Sciences Ireland UC
People needed: 35
Starts: 2026-08-03
Expected to finish: 2029-08-03
Last updated by the study team: 2026-08-05

Who can join

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

You may qualify if…

Participant 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 the drug
Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
Participant must sign an informed consent form (ICF) allowing data collection and 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

Full record on ClinicalTrials.gov

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