A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting
Observational · No treatment assigned · Sites not listed yet · Janssen-Cilag Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colitis, Ulcerative, Crohn Disease and Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- The participant has provided signed informed consent
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-10-05 (planned).
- Main results expected around 2029-07-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Main thing being measured
- Persistence of Treatment with Guselkumab (Up to Week 96)
In the researchers’ words
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),…
Words you might see
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases |
| Lead sponsor | Janssen-Cilag Ltd. |
| Enrollment | 200 (estimated) |
| Start date | 2026-10-05 |
| Primary completion (est.) | 2029-07-31 |
| First posted | 2026-10-01 |
| Last updated | 2026-10-01 |
| Official title | Guselkumab Assessment in Moderate-to-Severe Inflammatory Bowel Disease (IBD) Observational Study in a Real Life Italian Setting |
| ClinicalTrials.gov ID | NCT07851207 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion criteria: * 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 Exclusion criteria: * The participant is currently enrolled in an interventional clinical study * 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 * The participant has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy, including biologics and/or small molecules * 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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.