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Not Yet Recruiting NCT07851207

A Study to Assess Guselkumab in Participants With Moderate-to-Severe Inflammatory Bowel Disease in Real Life Italian Setting

Conditions: Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Janssen-Cilag Ltd.

Summary

The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) receiving guselkumab in a real-world setting, and to evaluate treatment persistence (continuation) and clinical effectiveness (how well it works) in the overall population and in predefined participant subgroups. The study will also assess patient-reported outcomes, including fatigue (low energy), health-related quality of life (HRQoL), and treatment satisfaction. CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system).

Eligibility Criteria

Inclusion criteria: * The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in the medical records * The participant must be eligible for biologic treatment and scheduled to initiate treatment with guselkumab for CD or UC management as per physician decision under routine clinical practice conditions, and according to the summary of product characteristics (SmPC) of the drug * The participant has provided signed informed consent Exclusion criteria: * The participant is currently enrolled in an interventional clinical study * The participant has been previously exposed to interleukin (IL)-23 inhibitors, including guselkumab (Tremfya), risankizumab (Skyrizi) or mirikizumab (Omvoh). As an exception, participants who had previously received ustekinumab may be included * The participant has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy, including biologics and/or small molecules * The participant is unable to provide the informed consent form (ICF) and/or unable to complete the questionnaires/scales and patient's diary to address the study objectives

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

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07851207). StuddyBuddy aggregates publicly available trial information.