Real-world Study of Remibrutinib Treatment for Chronic Spontaneous Urticaria in German Clinical Practice Observational Safety and Effectiveness Assessment

What this Trial Is About

Researchers are conducting a prospective, non-interventional study on patients with chronic spontaneous urticaria CSU who have already decided to switch or escalate their treatment to remibrutinib. The study aims to collect real-world data on how effective and safe remibrutinib is across a broader group of patients in routine clinical practice, focusing on outcomes in Germany as part of a global program. Participants are grouped based on their prior treatment one group includes those with inadequate control of CSU despite standard or increased doses of second-generation H1-antihistamines sgH1-AH, and the other includes those who have received other treatments alongside H1-antihistamines. Baseline assessments are done before starting remibrutinib, with follow-up visits monitoring clinical outcomes under remibrutinib treatment according to local guidelines. During the study, participants undergo clinical assessments and complete electronic diaries and questionnaires over a follow-up period of 24 months. Researchers measure disease control using tools like the Urticaria Control Test UCT and Urticaria Activity Score UAS7, quality of life, need for rescue medication, relapse characteristics, and adverse events. The primary outcome is disease control 12 weeks after initiating remibrutinib. This long-term monitoring helps to understand treatment effectiveness and safety in everyday clinical settings.

Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)