A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
NCT07102368 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2026-05-13
Summary
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
- Inflammatory Bowel Disease
- Colitis, Ulcerative
- Crohn's Disease
Sponsors & Collaborators
-
Janssen-Cilag G.m.b.H
lead INDUSTRY
Principal Investigators
-
Janssen-Cilag G.m.b.H, Germany Clinical Trial · Janssen-Cilag G.m.b.H
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-18
- Primary Completion
- 2029-01-15
- Completion
- 2029-01-15
Countries
- Germany
Study Locations
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