NCT07606339Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 35 (estimated)
- First submitted
- 19 May 2026
- Start date
- 10 Jun 2026
- Primary completion date
- 10 Jun 2029
- Lead sponsor
- Janssen-Cilag Pharma GmbH
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07606339
What you commit to
- Study type: Observational
- Planned participants: 35
- From 10 Jun 2026 to the primary completion date, 10 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
Other
- Contraindicated to guselkumab per the label
- Is currently enrolled in an interventional clinical study
- Is unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.