NCT07746765Not yet recruiting
A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
Real-world Observational 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 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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 35 (estimated)
- First submitted
- 31 Jul 2026
- Start date
- 12 Nov 2026
- Primary completion date
- 3 Aug 2029
- Lead sponsor
- Janssen Sciences Ireland UC
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07746765
What you commit to
- Study type: Observational
- Planned participants: 35
- From 12 Nov 2026 to the primary completion date, 3 Aug 2029
- No sites listed in no 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.