A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab
Recruiting · NCT07532213 · Observational (researchers observe without assigning treatment) · Lead sponsor: Janssen-Cilag A.G., Switzerland
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)
- Must have confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records
- Must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements
Exclusion criteria
- Contraindicated to guselkumab per the label
- Is currently enrolled in an interventional clinical study
- Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included
- History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)
- Is unable to provide informed consent
Where it is running
2 locations listed.
- Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern - Bern, Switzerland
- Gastroenterologische Praxis und Crohn-Collitis Zentrum Bern - Bern, Switzerland