A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn’s Disease in the United Kingdom (UK)
25 March 2026
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🅇 This trial is currently recruiting participants in the UK
Speak to your GP or specialist first. They can help you understand if you might be eligible and what taking part would involve.
🅇 This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
N/A
Participants
ALL
Age Range
18 Years+
About This Trial
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.
Who Can Join?
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…
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