A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
100 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov