RecruitingNCT07242248

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK


Sponsor

Janssen-Cilag Ltd.

Enrollment

220 participants

Start Date

Nov 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a real-world observational study tracking how guselkumab — a biologic drug that targets inflammation — works in patients with moderate-to-severe Crohn's disease or ulcerative colitis (two inflammatory bowel diseases) in real clinical settings in the UK, outside of a controlled trial. **You may be eligible if...** - You have been diagnosed with moderate-to-severe Crohn's disease or ulcerative colitis - Your doctor has decided to prescribe guselkumab based on approved guidelines for your condition - You enroll before or at the time of your first dose of guselkumab - You can sign a consent form allowing your records to be used for research **You may NOT be eligible if...** - There is a medical reason you should not take guselkumab (a contraindication listed on the drug label) - You are currently enrolled in an interventional clinical trial of guselkumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

London North West University Healthcare NHS Trust

Harrow, United Kingdom

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NCT07242248


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