Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease
Official title: GO-ON: Guselkumab lOngterm Persistency in Adult Patients With inflammatOry Bowel Disease: a Real World, National Non-iNterventional Study
Run by Janssen Research & Development, LLC · NCT07822529 · Data updated 2026-11-12
This study looks at how long adults with Crohn's disease or ulcerative colitis stay on guselkumab in real-world care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | guselkumab, risankizumab, mirikizumab, ustekinumab |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | September 14, 2026 |
| Main results expected | January 1, 2030 |
| Study ends | April 15, 2030 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07822529 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a confirmed moderate-to-severe Crohn's disease or ulcerative colitis who are starting guselkumab per approved indications and are managed by a physician.
✕Probably not a fit
Patients who discontinue guselkumab early for reasons unrelated to efficacy or safety may not experience a direct therapeutic benefit from continued use.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adults with moderate-to-severe Crohn's disease or ulcerative colitis to see how persistently they use guselkumab in routine clinical practice. It does not specify a formal treatment protocol beyond standard-of-care prescribing. The study relies on existing medical records and physician decisions to determine how long patients continue the therapy. Enrollment occurs around the time of the first guselkumab administration under current indications. Primary outcomes focus on treatment persistency and patterns over time.
Why it matters
Potential benefit: If successful, the study could clarify real-world persistence with guselkumab and help doctors understand long-term adherence in inflammatory bowel disease.
How similar studies have gone: Real-world persistence studies with biologics in inflammatory bowel disease have provided actionable insights, though this exact IL-23 inhibitor approach is less well characterized in long-term use.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Must be greater than or equal to (\>=) 18 years old * 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 the 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 (but after treatment decision by physician) * Must have a confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative Colitis (UC) recorded in their medical records * Participant has received the information note/given his/her oral agreement and has not objected to the collection of their data 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 a prior history of Stelara (ustekinumab) and biosimilars exposure, may be included * History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
Where it's running
-
CHU Amiens Picardie
Amiens, France Recruiting
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.