Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program (POP)

Study type

• Study topic:
  Disease /health condition

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

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, global, observational study

Study drug and medical condition

• Name of medicine:
  PLEGRIDY
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  Patients with multiple sclerosis (MS) aged 18 years or older, who were newly and currently prescribed Plegridy according to the local label under routine clinical care. The study also included patients participated in the Study 105MS302 (ATTAIN) or Study 105MS303 (ALLOW). The patients were identified from 160 sites in multiple regions, including the US, the United Kingdom (UK), the EU, Australia, Canada.; Inclusion criteria: ; • Patient and or legal representative is willing and able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations. ; • Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 or Study105MS303.; • Patient age 18 years or older.; • Patient willing and able to complete PROs with minimal assistance.; ; Exclusion criteria:; • Concurrent enrollment in any clinical trial of an investigational product. Participation in non interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the patient’s ability to comply with the protocol.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with multiple sclerosis
• Estimated number of subjects:
  1208

Study design details

• Main study objective:
  The primary purpose of this study is to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice.
• Outcomes:
  Safety of Plegridy will be evaluated by assessment of the incidence proportion and incidence rate of SAEs, Effectiveness of Plegridy on clinical no evidence of disease activity (cNEDA) will be evaluated by assessment of the proportion of patients with no relapses and no disability progression. Plegridy prescription and utilization adherence patterns, specific long-term clinical effectiveness of Plegridy, safety and tolerability of Plegridy, effect of FLS on patient-reported effectiveness of and satisfaction with prophylactic management using a FLS-Visual Analog Scale (VAS), change in HRQoL, FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.
• Data analysis plan:
  Descriptive analyses will be performed to gain a better understanding of the qualitative and quantitative nature of the data collected and the characteristics of the sample studied. Categorical variables will be summarized as number and proportion of the total study population and by subgroups where appropriate. Continuous variables will be reported as mean (and standard deviation) or median and range, where appropriate. Categorical outcomes on healthcare resource consumption, treatment adherence, patient determined disease steps (PDDS), and Plegridy prescription and utilization patterns will be summarized using frequencies and percentages. If necessary, a 95% CI based on binomial distribution might be provided for some of the categorical variables like patient adherence.