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.

NCT Number	NCT07102368
Lead Sponsor	Janssen-Cilag G.m.b.H
Conditions	Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn's Disease
Enrollment	500 participants
Start Date	2025-08-18
Primary Completion	2029-01-15 (estimated)
Study Completion	2029-01-15 (estimated)
Updated on ClinicalTrials.gov	2026-07-06