NCT07541261Recruiting
A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
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
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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 intestine.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 12 May 2026
- Primary completion date
- 2 Jan 2029
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07541261
What you commit to
- Study type: Observational
- Planned participants: 100
- From 12 May 2026 to the primary completion date, 2 Jan 2029
- 1 site in 1 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
- 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
Other illness
- History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
Other
- Contraindicated to guselkumab per the label
- Is currently enrolled in an interventional clinical study
- Is unable to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al Salama Hospital Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.