Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA60) remibrutinib

  remibrutinib
• Medical condition to be studied:
  Chronic spontaneous urticaria

Population studied

• Short description of the study population:
  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
• Estimated number of subjects:
  3277

Study design details

• Study design:
  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
• Main study objective:
  Evaluate the 12-week real-world effectiveness of remibrutinib in adult patients diagnosed with CSU who remain inadequately controlled despite sgH1-AHs (including all patients who initiate remibrutinib, regardless of prior treatment).; ;
• Setting:
  This is a 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 at a wider range of sites than in the Phase 2 and Phase 3 (REMIX) development trials. ; The study employs an umbrella design which brings together the evidence needs from multiple countries under the REASSERT global program. ; Countries will generate local study documentation (i.e. concept, protocol, SAP) to be applied in their country; the local study documentation will be a minimised version of the global document set, modified to align with country’s evidence needs, given local disparities in treatment guidelines, access, physician type and ePROs/eDiaries used. To achieve the core objectives the observation needs to include either the Urticaria Control Test (UCT) or Urticaria Activity Score over 7 days (UAS7) and the Dermatology Life Quality Index (DLQI). These, and safety data must be observed across all participating countries. ; Data from all countries will be pooled and analyzed globally. In certain instances, some modifications of the global protocol may be permitted. For example, in countries where prospective monitoring of off-label antihistamines is prohibited, cohort 1 will not be enrolled. ;