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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07102368 on ClinicalTrials.gov