Actively Recruiting
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
Led by Janssen-Cilag Ltd. · Updated on 2026-05-08
220
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be eligible for biologic treatment and start Guselkumab according to approved guidelines decided by the treating physician
- Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease or Ulcerative Colitis recorded in medical records
- Must sign an informed consent form allowing data verification as required locally
You will not qualify if you...
- Contraindicated to Guselkumab according to its label
- Currently enrolled in an interventional clinical study
- Previously treated with interleukin-23 inhibitors including Guselkumab, Risankizumab, or Mirikizumab, except if previously treated with Ustekinumab
- History of more than 4 lines of advanced inflammatory bowel disease therapy (biologics or small molecules)
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
London North West University Healthcare NHS Trust
Harrow, United Kingdom, HA1 3UJ
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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