A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
Observational · No treatment assigned · 1 site · Janssen-Cilag Pharma GmbH
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease and Colitis, Ulcerative. 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…
- 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 35 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-06-10.
- Main results expected around 2029-06-10 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Austria.
Groups in this study
- Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Main thing being measured
- Persistence with Guselkumab Treatment (Up to Week 96)
In the researchers’ words
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.
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Colitis, Ulcerative |
| Lead sponsor | Janssen-Cilag Pharma GmbH |
| Enrollment | 35 (estimated) |
| Start date | 2026-06-10 |
| Primary completion (est.) | 2029-06-10 |
| First posted | 2026-05-26 |
| Last updated | 2026-09-25 |
| Official title | Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT07606339 |
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 * 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 |
|---|---|---|---|
| Medical University Vienna | Vienna | Austria | 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.