A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
Recruiting now
Conditions studied: Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn's Disease
In brief
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 inflammatory conditions of the colon and small intestine.
Key facts
- Study ID
- NCT07242248
- Run by
- Janssen-Cilag Ltd.
- People needed
- 220
- Starts
- 2025-11-17
- Expected to finish
- 2029-03-17
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- London North West University Healthcare NHS Trust — Harrow, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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