NCT07541261 A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia
| NCT ID | NCT07541261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2029-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-05-12 with a primary completion date of 2029-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07541261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541261 currently recruiting?
Yes, NCT07541261 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07541261 trial being conducted?
This trial is being conducted at Jeddah, Saudi Arabia.
Who is sponsoring the NCT07541261 clinical trial?
NCT07541261 is sponsored by Janssen Research & Development, LLC. The trial plans to enroll 100 participants.