Remibrutinib in Real-world Clinical Practice
ConditionChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals
About this trial
Prospective, multi-country, 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.
Eligibility criteria
Qualifiers
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 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.
Disqualifiers
Currently enrolled in a clinical trial or on any experimental treatment.
Patients within the safety follow-up phase of a previous interventional or non-interventional study.
Patients who received remibrutinib as an investigational medical product during a remibrutinib interventional study or MAP/PSDS at any time in the past.
Patients not capable or willing to continuously provide ePRO/eDiary data via electronic means throughout the duration of the study.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
3,280 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov