Status: Recruiting
A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
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.
Participants needed: 500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Janssen-Cilag G.m.b.HUpdated: Jun 5, 2026Locations: 1
Eligibility criteria
Must be eligible for biologic treatment and initiate guselkumab according to the... [+2]
Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD)... [+3]