Actively Recruiting
A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Led by Janssen-Cilag G.m.b.H · Updated on 2026-05-13
500
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.
CONDITIONS
Official Title
A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible for biologic treatment and starting guselkumab as per approved guidelines
- Signed informed consent allowing data collection and verification
- Able and willing to complete patient-reported outcome assessments during the study
You will not qualify if you...
- History of more than 4 lines of advanced inflammatory bowel disease therapy
- Previous exposure to interleukin-23 inhibitors, except ustekinumab
- Previous colectomy and/or pouch surgery
- Currently enrolled in an interventional clinical study or another non-interventional Janssen or Johnson & Johnson study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Praxis Fur Gastroenteroligie
Berlin, Germany, 10825
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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