Observational Study of Guselkumab Treatment in Adults with Moderate to Severe Crohns Disease Previously Treated with Ustekinumab

What this Trial Is About

This research aims to evaluate the effectiveness and safety of guselkumab in adults aged 18 to 75 years with moderate to severe Crohns disease who have previously not responded to or could not tolerate ustekinumab treatment. The study focuses on patients with a diagnosis of Crohns disease for at least 3 months and seeks to address the limited data available for guselkumab use in this specific group. It is a prospective, single-center observational study that plans to enroll about 60 participants. Participants will receive guselkumab following a defined induction and maintenance treatment regimen, with the entire observation lasting 52 weeks. The study will monitor the patients without altering their usual care, focusing on the real-world effects of guselkumab after prior ustekinumab therapy. No placebo or comparator drugs are involved, as this is an observational study. During the study, participants will attend scheduled visits for clinical assessments, including measurement of disease activity scores and quality of life evaluations. Researchers will track clinical remission rates at Week 52, along with other measures such as clinical response, endoscopic improvement, biomarker normalization, and safety. The study includes close safety monitoring and quality of life questionnaires to understand the treatment impact comprehensively.

A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab