Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Certified Prescribers to Assess Understanding of the Risks with the BKEMV™ Risk Evaluation and Mitigation Strategy (REMS) (20240216)

Study type

• Study topic:
  Human medicinal product

  Other
• Study topic, other:
  US-based, observational, cross-sectional survey of HCPs who are currently prescribing or with potential to prescribe BKEMV.
• Study type:
  Non-interventional study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name, other:
  BKEMV (eculizumab-aeeb)
• Study drug International non-proprietary name (INN) or common name:
  ECULIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AJ01) eculizumab

  eculizumab
• Medical condition to be studied:
  Atypical haemolytic uraemic syndrome

  Myasthenia gravis

  Paroxysmal nocturnal haemoglobinuria

Population studied

• Short description of the study population:
  The survey will target BKEMV REMS-certified prescribers identified via the BKEMV REMS-database and who have not been debarred or sanctioned.
• 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:
  83

Study design details

• Study design:
  This US-based, observational, cross-sectional survey involves healthcare providers (HCPs) certified in BKEMV REMS and not debarred or sanctioned. ; It is self-administered via internet/telephone using a validated vendor survey platform.
• Main study objective:
  HCPs must understand the increased risk of meningococcal infections with BKEMV use, the need for vaccination against Neisseria meningitidis serogroups A, C, W, Y, and B per ACIP guidelines, and the importance of counseling patients on signs and symptoms using the Patient Safety Card and Guide.
• Setting:
  Online survey
• Comparators:
  N/A
• Outcomes:
  The primary endpoint of the study is: ; • The number of respondents who score 80% or greater in each key message domain;
• Data analysis plan:
  Statistical analyses will be descriptive in nature. ; Counts and percentages will be calculated for each question/item in the questionnaire. ; 95% confidence intervals (CIs) for the survey end points will be calculated to provide an estimate of precision; however no formal hypothesis will be tested. ; All CIs around the percentages will be exact binomial 2-sided 95% CIs calculated according to the method of Clopper-Pearson. ; Analyses will be performed at the respondent level; therefore, within-respondent variation is not relevant.;