Guselkumab treatment for Crohn's disease and ulcerative colitis in Germany

Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects

This project will try to see how well guselkumab works and how it affects symptoms, quality of life, and daily activities for adults with Crohn's disease or ulcerative colitis receiving routine care in Germany.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Janssen-Cilag G.m.b.H (industry)
• Drugs / interventions: guselkumab, ustekinumab
• Locations: 1 site (Berlin)
• Trial ID: NCT07102368 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, real-world observational cohort that follows people who start guselkumab for Crohn's disease or ulcerative colitis according to approved indications. Clinical outcomes and routine medical data will be collected alongside patient-reported outcomes such as fatigue, health-related quality of life, sexuality, work productivity, and treatment satisfaction. The study will describe baseline characteristics and compare effectiveness across participant subgroups while excluding those with prior IL-23 exposure (except ustekinumab), prior colectomy/pouch, or more than four prior lines of advanced IBD therapy. Data will be captured during regular clinic visits and through standardized questionnaires without changing prescribed care.

Who should consider this trial

Good fit: Adults in Germany with Crohn's disease or ulcerative colitis who are starting guselkumab for an approved indication, can give informed consent, are willing to complete patient-reported outcome questionnaires, have not had more than four prior lines of advanced IBD therapy, and have not previously received IL-23 inhibitors (except ustekinumab).

Not a fit: Patients previously exposed to IL-23 inhibitors (other than ustekinumab), those with a colectomy or pouch, or those with more than four prior lines of advanced IBD therapy are unlikely to be eligible or to gain useful data from this project.

Why it matters

Potential benefit: If successful, this project could help clinicians understand who benefits most from guselkumab and guide treatment choices in everyday practice.

How similar studies have performed: Some clinical trials and studies of IL-23–targeting therapies have shown promise in IBD, but real-world effectiveness data for guselkumab remain limited.

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)

Where this trial is running

Berlin

• Praxis Fur Gastroenteroligie — Berlin, Germany (RECRUITING)

Study contacts

• Study coordinator: Study Contact

Conditions: Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn's Disease, IBD, Ulcerative Colitis, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases