Observational Study of Canakinumab Ilaris for Treating Schnitzlers Syndrome Including Patients Starting Treatment for the First Time

What this Trial Is About

Researchers are evaluating the use of Ilaris canakinumab in patients diagnosed with Schnitzlers syndrome to assess how well it works and how safe it is in real-world clinical settings. This observational study focuses on people who are using canakinumab for the first time to treat this rare condition. The study is sponsored by Novartis Pharmaceuticals and aims to gather detailed information about treatment responses and safety outcomes. Participants in this study will be those starting canakinumab treatment for Schnitzlers syndrome as per the approved indications. The study observes patients over time without changing or assigning treatments, registering all diagnosed patients who receive canakinumab, including those who began treatment before the study contract was finalized. It excludes patients previously treated with canakinumab in a specific prior study or those treated for other related inflammatory syndromes or off-label uses. Throughout the study, researchers will monitor patients clinical responses, including complete or partial improvement rates from the first week up to 48 weeks after starting treatment. They will also track various blood markers such as white blood cell counts, neutrophil counts, C-reactive protein levels, alkaline phosphatase, and immunoglobulin levels at multiple time points. Safety is assessed by recording adverse reactions and serious events throughout the observation period. The total study duration extends up to June 2032, allowing long-term follow-up of participants.

A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome