Remibrutinib in real-world clinical practice: a prospective, multi-country, non-interventional, effectiveness and safety study (REASSERT) - Local adaptation in Germany from global umbrella protocol (CLOU064A2402)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Healthcare resource utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

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 escalate/switch current treatment to remibrutinib
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  470

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 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 symptomatic despite sgH1-AHs.
• Setting:
  The study is conducted in various healthcare system settings, office- and hospital-based.