Crohn'sUCRecruiting
A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
Observational · No treatment assigned · 1 site · Janssen Research & Development, LLC
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: 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:
- The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision…
- The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
- The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification
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 100 participants are expected to take part.
- Start date: 2026-05-12.
- Main results expected around 2029-01-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Saudi Arabia.
Main thing being measured
- Time to Guselkumab Discontinuation (Up to Week 96)
In the researchers’ words
The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) 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…
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 | Colitis; Ulcerative; Crohn Disease |
| Lead sponsor | Janssen Research & Development, LLC |
| Enrollment | 100 (estimated) |
| Start date | 2026-05-12 |
| Primary completion (est.) | 2029-01-02 |
| First posted | 2026-04-21 |
| Last updated | 2026-07-02 |
| Official title | A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia |
| ClinicalTrials.gov ID | NCT07541261 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent * The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records * The participant must sign a participation agreement/informed consent form (ICF) allowing source data verification 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 |
|---|---|---|---|
| Al Salama Hospital | Jeddah | Saudi Arabia | 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.