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

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT07242248
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Nov 21, 2025
Start date
Nov 17, 2025
Status verified
Jul 2026
Primary completion
Mar 5, 2029
Completion
Mar 17, 2029

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
    Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected.

Primary Outcome Measure

Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) [ Time Frame: Up to Week 96 ]

Central Contacts

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