NCT07102368

A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany

Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Janssen-Cilag G.m.b.H · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-08-18
• Primary completion: 2029-01-15
• Completion: 2029-01-15
• First posted: 2025-08-03
• Last updated: 2026-04-13

Locations

1 site across 1 country: Germany