Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK
Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK
This project will see how well guselkumab works for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting the treatment in routine UK care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen-Cilag Ltd. Industry-sponsored |
| Drugs / interventions | guselkumab, risankizumab, mirikizumab, ustekinumab |
| Locations | 1 site (Harrow) |
| Trial ID | NCT07242248 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of moderate-to-severe ulcerative colitis or Crohn's disease who are eligible for and starting guselkumab per their physician, can consent, and have not previously received IL-23 inhibitors are ideal candidates.
Not a fit: Patients who are contraindicated to guselkumab, already treated with IL-23 inhibitors, or currently enrolled in an interventional trial are unlikely to be eligible or to benefit from this observational data.
Why it matters
Potential benefit: If successful, this could show how guselkumab performs in everyday NHS practice and help doctors choose which patients may benefit.
How similar studies have performed: Other IL-23 inhibitors such as risankizumab and mirikizumab have shown efficacy in trials for IBD, but real-world data specifically for guselkumab in UC and Crohn's disease remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Harrow
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.