A Survey of Healthcare Professionals in Europe to Evaluate the Effectiveness of the ENJAYMO™ Physician’s Guide

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  Enjaymo
• Study drug International non-proprietary name (INN) or common name:
  SUTIMLIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA55) sutimlimab
• Medical condition to be studied:
  Cold agglutinins
• Additional medical condition(s):
  Cold agglutinin disease

Population studied

• Short description of the study population:
  The current study is planned to be conducted among HCPs in countries in the EEA where the product is expected to be commercially available for at least 6 months.
• 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:
  50

Study design details

• Study design:
  This is a multinational, non-interventional, cross sectional survey study to evaluate the effectiveness of the ENJAYMO™ Physician’s Guide among EEA-based HCPs.
• Main study objective:
  To assess HCPs’ knowledge levels of key information included in the ENJAYMO™ Physician’s Guide across these 4 domains:; ⦁ Indication for cold agglutinin disease (CAD) patients only; ⦁ Important potential risks of serious infections including meningococcal infections; ⦁ Recommendations for vaccination of patients as per local regulations ; ⦁ Recommendations for monitoring and counseling patients to promote real-world safe-use conditions
• Outcomes:
  HCPs’ knowledge levels of key information included in the ENJAYMO™ Physician’s Guide
• Data analysis plan:
  Descriptive data analyses will be conducted for all primary and secondary objectives. Descriptive statistics for continuous data will include N, means, and standard deviations. Results for some continuous variables may include ranges (minimums and maximums) and medians as well. Categorical data will be summarized using frequency counts and percentages. Knowledge levels will be calculated with 95% 2-sided CI. Knowledge levels will also be stratified by items with potential to confound the knowledge level (e.g., country, specialty, reads/uses vs. did not read/does not use the ENJAYMO™ Physician’s Guide, prescribing status). Missing data will be reported, but no replacement or imputation will be performed.
• Summary results:
  Not applicable