A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis
- Crohn Disease
- Colitis, Ulcerative
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Janssen-Cilag Pharma GmbH
- Enrolment target
- 35
- Started
- 10 June 2026
- Main results due
- 10 June 2029
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion criteria: * 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 * 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 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
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to evaluate 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.
Study sites(1)
Medical University Vienna
Vienna, Austria
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07606339. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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