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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Praxis Fur Gastroenteroligie
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Long-term evaluation of guselkumab for children with inflammatory bowel disease and juvenile arthritis

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• Guselkumab use in Crohn's disease and ulcerative colitis

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• Magnesium status in people with IBD, ileostomy, or bile acid diarrhea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.