A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab
Observational · No treatment assigned · 1 site · Janssen-Cilag A.G., Switzerland
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease, Colitis, Ulcerative and Crohn Disease. 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:
- 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…
- Must have 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
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2026-04-13.
- Main results expected around 2029-04-10 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Switzerland.
Main thing being measured
- Time to Guselkumab Persistence (Up to Week 96)
In the researchers’ words
The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease; Colitis, Ulcerative; Crohn Disease |
| Lead sponsor | Janssen-Cilag A.G., Switzerland |
| Enrollment | 50 (estimated) |
| Start date | 2026-04-13 |
| Primary completion (est.) | 2029-04-10 |
| First posted | 2026-04-15 |
| Last updated | 2026-06-12 |
| Official title | Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes |
| ClinicalTrials.gov ID | NCT07532213 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 (but after treatment decision by physician) * Must have 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 criteria: * Contraindicated to guselkumab per the label * Is currently enrolled in an interventional clinical study * 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) * Is unable to provide informed consent
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern | Bern | Switzerland | Recruiting |
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.