NCT07606339 A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis
| NCT ID | NCT07606339 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen-Cilag Pharma GmbH |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-06-10 |
| Primary Completion | 2029-06-10 |
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 35 participants in total. It began in 2026-06-10 with a primary completion date of 2029-06-10.
⚠ 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 purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
Eligibility Criteria
Inclusion criteria: * Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration * Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records * Must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements 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
Janssen-Cilag Pharma GmbH Clinical Trial
STUDY DIRECTOR
Janssen-Cilag Pharma GmbH
Frequently Asked Questions
Who can join the NCT07606339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07606339 currently recruiting?
Yes, NCT07606339 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07606339 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07606339 clinical trial?
NCT07606339 is sponsored by Janssen-Cilag Pharma GmbH. The principal investigator is Janssen-Cilag Pharma GmbH Clinical Trial at Janssen-Cilag Pharma GmbH. The trial plans to enroll 35 participants.