A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
Recruiting · NCT07541261 · Observational (researchers observe without assigning treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Al Salama Hospital - Jeddah, Saudi Arabia
- Al Salama Hospital - Jeddah, Saudi Arabia