Studies guselkumab in adults with Crohn's disease and ulcerative colitis
Observes how guselkumab works in routine care for adults with Crohn's or colitis.
Plain-language title generated from the registry record
Registry title: A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Key facts
- Where
- Berlin, GermanySee the site
Where in Germany
- Praxis Fur GastroenteroligieBerlin, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen-Cilag G.m.b.H
- Trial code
- NCT07102368
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects
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.
Inclusion: Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics; Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements; By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study.
Exclusion: Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included; Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy; Has had a colectomy and/or a pouch; Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \& Johnson (J\&J).