Observes how long people keep taking guselkumab for Crohn's or colitis
Follows adults with Crohn's disease or ulcerative colitis who take guselkumab in routine care.
Plain-language title generated from the registry record
Registry title: A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
Key facts
- Where
- Vienna, AustriaSee the site
Where in Austria
- Medical University ViennaVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen-Cilag Pharma GmbH
- Trial code
- NCT07606339
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis
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.
Inclusion: 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: 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); Contraindicated to guselkumab per the label; Is currently enrolled in an interventional clinical study; Is unable to provide informed consent.