About this trial
The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.
Eligibility criteria
Qualifiers
Participant 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 the drug
Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records
Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed