Crohn'sUCNot yet recruiting
A Real-World Study of Guselkumab Persistence and Effectiveness in Participants With Crohn's Disease or Ulcerative Colitis
Observational · No treatment assigned · Sites not listed yet · Janssen-Cilag, S.A.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Colitis, Ulcerative and Crohn Disease. 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:
- Participant 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…
- Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for…
- Participant \[and/or their legally-acceptable representative where applicable\] must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-10-30 (planned).
- Main results expected around 2029-06-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Main thing being measured
- Persistence of Treatment with Guselkumab (Up to 96 weeks)
In the researchers’ words
The purpose of this study is to evaluate how long participants with moderate-to-severe Crohn's Disease (CD) and Ulcerative Colitis (UC) continue treatment with guselkumab in a real-world setting. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).
Words you might see
- Mayo score: a score used to measure how active ulcerative colitis is.
- 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 | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Colitis, Ulcerative; Crohn Disease |
| Lead sponsor | Janssen-Cilag, S.A. |
| Enrollment | 200 (estimated) |
| Start date | 2026-10-30 |
| Primary completion (est.) | 2029-06-30 |
| First posted | 2026-09-30 |
| Last updated | 2026-09-30 |
| Official title | Guselkumab: A Real Life Non-Interventional, Persistence and Effectiveness Study in Patients With Crohn's Disease or Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT07848737 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion criteria: * Participant 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. Participant must have been at least 8 weeks under guselkumab treatment before being included in the study, regardless if they are still on guselkumab treatment or not * Participant must have a confirmed diagnosis of moderate-to-severe or Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records: Harvey-Bradshaw Index (HBI) greater than (>)4 for CD and Partial Mayo Score (pMS)>2 for UC * Participant \[and/or their legally-acceptable representative where applicable\] 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 * It 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 the ICF
Locations (0)
No sites listed yet. The official record has contact information.
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.