An Observational, Cross-Sectional Survey to Assess PML Risk Awareness and Understanding from Patients’ Perspective and Effectiveness of the Tysabri (Natalizumab) Patient Alert Card in the UK (T-PAC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Questionnaire on Patient Alert Card recall

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  TYSABRI
• Study drug International non-proprietary name (INN) or common name:
  NATALIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG03) natalizumab

  natalizumab
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  700

Study design details

• Main study objective:
  This study’s research questions are to assess: ; • What is the patient’s overall awareness of PML? ; • How effective is the Tysabri (natalizumab) PAC in educating patients to ensure they are aware of the risk of PML whilst receiving Tysabri treatment (and for up to 6 months after stopping Tysabri), and exercise vigilance regarding its development?
• Outcomes:
  The primary objectives of the study are to assess the following in patients treated with Tysabri (natalizumab) in the UK: ; • The level of PML risk awareness ; • The effectiveness of the Tysabri (natalizumab) PAC in conveying the risk of PML to patients
• Data analysis plan:
  Descriptive analyses of UK MS Register patients will be performed by UK MS Register to characterise the study population (RRMS patients receiving Tysabri IV or SC). Summary statistics such as mean and standard deviation for continuous variables and frequency table for categorical variables will be provided. Data analyses will generally be descriptive and will be detailed in the SAP. Patient understanding of the PAC and the symptoms of PML will be determined for Tysabri IV and Tysabri SC patients. The proportion of patients who have good, fair, and poor knowledge of PML symptoms and risk factors in determining the knowledge will be assessed. Specifically, PML knowledge will be stratified based on receipt of HCP- and patient-related metrics (provided in the SAP) to determine the effectiveness of the PAC in conveying knowledge of PML to patients.