A post-authorisation safety study (PASS) to describe real-world safety and effectiveness of NUCALA (mepolizumab) in paediatric eosinophilic granulomatosis with polyangiitis (EGPA) patients in Europe (218065)

Study type

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

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Medicinal product name:
  NUCALA
• Study drug International non-proprietary name (INN) or common name:
  MEPOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX09) mepolizumab

  mepolizumab
• Medical condition to be studied:
  Eosinophilic granulomatosis with polyangiitis

Population studied

• Short description of the study population:
  The study will include paediatric EGPA patients treated with mepolizumab
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  10

Study design details

• Study design:
  multinational, multi-site, case-series
• Main study objective:
  The primary objective of this study is to describe the real-world safety of mepolizumab treatment in paediatric EGPA patients aged 6 to 17 years in terms of AEs, SAEs, pregnancy exposures and medical device incidents.
• Setting:
  routine clinical care from sites in selected countries in Europe
• Data analysis plan:
  Data from this study will be described per patient as a case series, as the sample size will be insufficient to perform statistical analyses or summarise across patients.