RecruitingNCT07102368

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


Sponsor

Janssen-Cilag G.m.b.H

Enrollment

400 participants

Start Date

Aug 18, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study in Germany is collecting real-world information on how well guselkumab — a biologic injection — works for people with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. **You may be eligible if...** - You live in Germany and have inflammatory bowel disease - Your doctor has decided to start you on guselkumab as part of your standard care - You are willing to complete periodic questionnaires about your symptoms and quality of life **You may NOT be eligible if...** - You have already tried four or more different advanced IBD treatments (biologics or other) - You have previously used a different IL-23 inhibitor (note: prior use of ustekinumab may be acceptable) - You have had your colon removed (colectomy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Praxis Fur Gastroenteroligie

Berlin, Germany

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NCT07102368


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