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Real World Observation Of Guselkumab Treatment In Patients With Ulcerative Colitis And Crohns Disease - A Study Of Treatment Outcomes In The UK
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Actively Recruiting
Age: 18 Years +
All Genders
ID: 07242248
Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK
Led by: Janssen-Cilag Ltd.
Updated on: 2026-06-05
220 Participants Needed
1 Research Sites
1 week Total Duration
On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
AI-Summary
What This Trial Is About
This research aims to evaluate how well the treatment Guselkumab works for adults with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), which are major types of inflammatory bowel disease affecting the colon and small intestine. The study focuses on treatment outcomes in real-world clinical settings, looking at different treatment lines and patient subgroups to understand clinical effectiveness. Participants with confirmed moderate-to-severe UC or CD who are treated with Guselkumab as part of their usual care will be enrolled. No study drug will be given by the researchers instead, data from standard medical practice and patient records will be collected. The study will observe participants over time, up to 96 weeks, to assess various clinical outcomes and responses to the treatment. During the study, researchers will gather data on clinical remission and response using tools like the Harvey-Bradshaw Index for CD and Partial Mayo Score for UC. They will also monitor corticosteroid-free remission, patient-reported outcomes, and biomarkers such as C-reactive protein and faecal calprotectin. Additional assessments include quality of life questionnaires, endoscopic and histologic evaluations, and tracking of adverse events. The study will monitor participants health and treatment outcomes throughout the observation period, which lasts nearly two years.
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CONDITIONS
Brief 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
Age: 18 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Eligible for biologic treatment and starting guselkumab as prescribed by their physician
- Confirmed diagnosis of moderate-to-severe Crohn's Disease or Ulcerative Colitis in medical records
- Signed informed consent form allowing data verification according to local rules
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 those with prior ustekinumab exposure)
- History of more than 4 lines of advanced inflammatory bowel disease therapy
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 96 weeks
Participants who are starting guselkumab treatment as prescribed by their physician are observed through data collected from standard clinical practice and medical records.
Visits at Baseline, Weeks 1, 2, 4, 8, 12, 24, 48, 72, and 96
Trial Site Locations
Total: 1 location
- London North West University Healthcare NHS Trust
Harrow, United Kingdom, HA1 3UJ
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Research Team
Study 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
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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Sponsors
J
Janssen-Cilag Ltd.
Lead Sponsor
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