IBD (general)Recruiting
A Study of Long Term Persistency of Guselkumab in Adult Participants With Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · Janssen Research & Development, LLC
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 400 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-09-14.
- Main results expected around 2030-01-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Groups in this study
- Guselkumab
Main thing being measured
- Persistence with Guselkumab Treatment (Up to Week 96)
In the researchers’ words
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 diseases, a group of inflammatory conditions of the colon and small…
Words you might see
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Janssen Research & Development, LLC |
| Enrollment | 400 (estimated) |
| Start date | 2026-09-14 |
| Primary completion (est.) | 2030-01-01 |
| First posted | 2026-09-16 |
| Last updated | 2026-09-25 |
| Official title | GO-ON: Guselkumab lOngterm Persistency in Adult Patients With inflammatOry Bowel Disease: a Real World, National Non-iNterventional Study |
| ClinicalTrials.gov ID | NCT07822529 |
Interventions
- None listed
Full eligibility criteria (from the record)
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)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Picardie | Amiens | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.