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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to 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 enrollment.

Written informed consent of the patient to participate in the study and willingness to complete full follow-up period of 24 months.

Cohort 2: Inadequate control of CSU despite licensed dose or escalated sgH1-AH(s) (no other pre-treatment with exception of first generation H1-AH permitted) with decision (independent of study enrollment) to switch to remibrutinib treatment as per local label.

Disqualifiers

Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with remibrutinib.

Patients within the safety follow-up phase of a previous interventional or non-interventional study.

Patients who received remibrutinib 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

470 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators