Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study
Novartis Pharmaceuticals
Summary
Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.
Description
This is a prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population. This local US study is part of an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with a confirmed diagnosis of primary CSU by the treating physician. * Aged at least 18 years on the date of enrolment. * Written informed consent of the patient to participate in the study (according to country specifications) and willingness to complete full follow-up period of 24 months. * Cohort-specific observational inclusion criteria: * Cohort 1: Inadequate control of CSU despite licensed dose of sgH1-AH (no other pre-treatments permitted) and decision (independent of study enrolment) to escalate sgH1-AH treatment. * Cohort 2: Inadequate control of C…
Location
- Cleaver DermatologyKirksville, Missouri