Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07746765

A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting

Conditions: Crohn Disease, Colitis, Ulcerative

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 35
Sponsor: Janssen Sciences Ireland UC

Summary

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

Inclusion criteria: * 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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07746765). StuddyBuddy aggregates publicly available trial information.