Crohn'sUCRecruiting
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
Observational · No treatment assigned · 1 site · Janssen-Cilag Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease, Colitis, Ulcerative and Crohn's 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:
- 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
- Must sign a 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 220 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-11-17.
- Main results expected around 2029-03-05 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Groups in this study
- Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Main thing being measured
- Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) (Up to Week 96)
- Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS) (Up to Week 96)
- Number of Participants Achieving Clinical Response for CD as Measured by HBI (Up to Week 96)
In the researchers’ words
The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of…
Words you might see
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
- 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 Disease; Colitis, Ulcerative; Crohn's Disease |
| Lead sponsor | Janssen-Cilag Ltd. |
| Enrollment | 220 (estimated) |
| Start date | 2025-11-17 |
| Primary completion (est.) | 2029-03-05 |
| First posted | 2025-11-21 |
| Last updated | 2026-09-25 |
| Official title | Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK |
| ClinicalTrials.gov ID | NCT07242248 |
Interventions
- None listed
Full eligibility criteria (from the record)
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 the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's/ Health Board's treatment guidance. Enrolment must take place before or at the day of 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 * Must sign a 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 * Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and /or small molecules) * Is unable to provide informed consent
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| London North West University Healthcare NHS Trust | Harrow | United Kingdom | 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.