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
- Inflammatory Bowel Disease
- Colitis, Ulcerative
- Crohn's Disease
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Janssen-Cilag G.m.b.H
- Enrolment target
- 500
- Started
- 18 August 2025
- Main results due
- 15 January 2029
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. 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 2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements 3. 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 Criteria: 1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy 2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included 3. Has had a colectomy and/or a pouch 4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \& Johnson (J\&J)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Praxis Fur Gastroenteroligie
Berlin, Germany
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07102368. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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