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

Sponsor
Janssen-Cilag G.m.b.H
Study ID
NCT07102368
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 3, 2025
Start date
Aug 18, 2025
Status verified
Jul 2026
Primary completion
Jan 15, 2029
Completion
Jan 15, 2029

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
    Participants with confirmed diagnosis of moderate-to-severe UC or CD treated with guselkumab as per standard clinical practice will be enrolled. Only data available from clinical routine will be collected in this study. During the observational period, data will be collected at weeks 0 (baseline), 4, 8, 12, 24, 48, 72, and 96, where available as per clinical routine. The respective collection times relate to the first study dose of guselkumab.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI) [ Time Frame: Week 48 ]

Central Contacts

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