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Not yet recruiting NCT07541261

A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia

Conditions: Colitis Ulcerative Crohn Disease

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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 participate
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

Location information is not available.

Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.04.2026
Completion date
02.01.2029
Registry ID
NCT07541261
Source
clinicaltrials.gov
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