NCT07851207Not yet recruiting
A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting
Guselkumab Assessment in Moderate-to-Severe Inflammatory Bowel Disease (IBD) Observational Study in a Real Life Italian Setting
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Janssen-Cilag Ltd.
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07851207
What you commit to
- Study type: Observational
- Planned participants: 200
- From 5 Oct 2026 to the primary completion date, 31 Jul 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
- The participant has been previously exposed to interleukin (IL)-23 inhibitors, including guselkumab (Tremfya), risankizumab (Skyrizi) or mirikizumab (Omvoh). As an exception, participants who had previously received ustekinumab may be included
Other illness
- The participant has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy, including biologics and/or small molecules
Other
- The participant is currently enrolled in an interventional clinical study
- The participant is unable to provide the informed consent form (ICF) and/or unable to complete the questionnaires/scales and patient's diary to address the study objectives
Who the study is looking for
- The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in the medical records
- The participant must be eligible for biologic treatment and scheduled to initiate treatment with guselkumab for CD or UC management as per physician decision under routine clinical practice conditions, and according to the summary of product characteristics (SmPC) of the drug
- The participant has provided signed informed consent
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.