GUSTO - UK
Research type
Research Study
Full title
Real world observation of Guselkumab treatment in patients with Ulcerative Colitis and Crohn’s Disease - a Study of Treatment Outcomes in the UK: GUSTO - UK
IRAS ID
359429
Contact name
Ailsa Hart
Contact email
Sponsor organisation
Janssen Cilag Ltd.
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
Inflammatory bowel disease (IBD) includes conditions that cause inflammation in the colon (large intestine) and small intestine. The two main types of IBD are Crohn’s disease (CD) and Ulcerative Colitis (UC). While there is currently no cure for IBD, there are different treatments available to help manage the disease. Guselkumab is a new treatment recently approved for patients with moderate to severe UC or CD who have not responded well to other treatments or cannot tolerate them.
This study is observing patients with CD and UC who have just started taking guselkumab as part of their regular care at NHS sites.
The goal of the study is to see how well guselkumab works in everyday medical settings, rather than in a controlled clinical trial. Around 20 NHS sites will join the study, enrolling up to 220 patients who agree to participate.
Participants will be in the study for 96 weeks and will receive guselkumab treatment as directed by their doctor. At the beginning, the researchers will collect information about the patients' medical history and previous treatments. During the study, patients will fill out diary cards and questionnaires to share how they are responding to the treatment.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0175
Date of REC Opinion
10 Sep 2025
REC opinion
Further Information Favourable Opinion