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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate-to-severe Crohn's disease or ulcerative colitis who are starting guselkumab. It follows how long they keep taking it in everyday care.
- Age
- 18 Years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed moderate-to-severe Crohn's disease or ulcerative colitis in the medical records
- Earlier treatment
- Must be starting guselkumab as approved in the product information, with enrolment before or on the day of the first dose. Cannot have had IL-23 inhibitors before (people who had Ustekinumab may join). No more than 4 lines of advanced IBD therapy.
Main reasons for not taking part
- Contraindicated to guselkumab per the label
- Currently in an interventional clinical study
- Previous IL-23 inhibitor, such as Tremfya (guselkumab), Skyrizi (risankizumab) or Omvoh (mirikizumab)
- History of more than 4 lines of advanced IBD therapy (biologics and/or small molecules)
- Unable to give informed consent
Read by machine on 9 November 2026.
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.