Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry will follow adults in the UK who start guselkumab for moderate-to-severe ulcerative colitis or Crohn's disease, with enrollment before or at first dose per the treating physician's decision. Data will be collected from medical records to describe clinical outcomes by line of therapy and in predefined subpopulations while excluding patients previously treated with IL-23 inhibitors. No treatment is assigned by the protocol and patients receive care according to local NHS guidance, with source data verification performed after informed consent. The sponsor is Janssen-Cilag Ltd. and the initial site listed is London North West University Healthcare NHS Trust.

Why it matters

Who can join: the full rules

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

Where it's running

• London North West University Healthcare NHS Trust
  Harrow, United Kingdom Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Guselkumab use in Crohn's disease and ulcerative colitis

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• Magnesium status in people with IBD, ileostomy, or bile acid diarrhea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.