Healthcare Professional and Patient Surveys to Evaluate the Effectiveness of the Risk Minimisation Educational Materials for Certolizumab Pegol (CZP; CIMZIA®)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assessment of the effectiveness of the risk minimisation plan educational materials
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CERTOLIZUMAB PEGOL
• Medical condition to be studied:
  Axial spondyloarthritis

  Ankylosing spondylitis

  Psoriatic arthropathy

  Rheumatoid arthritis

Population studied

• Short description of the study population:
  The population for the healthcare professionals (HCP) survey was:; 1. HCPs who have prescribed or monitored patients receiving treatment with CZP; 2. HCPs who have not previously completed a survey regarding the risks of CZP; ; The population for the patient survey was:; 1. Patients who were male or female and were ≥18 years of age; 2. Patients who had not previously participated in any surveys about the educational tools for CZP; 3. Patients who had received ≥1 prescription of CZP within the last 6 months; 4. Patients who were not HCPs themselves (eg, a doctor, nurse, pharmacist)
• 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:
  295

Study design details

• Main study objective:
  To evaluate the effectiveness of the educational material risk minimisation measures being implemented in the EU, in healthcare professionals who are prescribing and/or administering CZP, and in patients who are prescribed CZP
• Outcomes:
  Proportion of respondents who received, were aware of, or accessed each of the CZP educational materials (Patient Alert Card and Prescriber Guide)
• Data analysis plan:
  To evaluate healthcare providers’ knowledge of the CZP educational materials, two key assessment measures will be required: - A presentation of the percentage of HCPs who received, were aware of or accessed each of the CZP educational materials and to what extent those materials were read- A summary of correct responses to each individual question on the understanding of CZPIn order to evaluate patients’ knowledge of the CZP educational materials program, two key assessment measures are required: - A presentation of the percentage of patients who received, were aware of, or accessed the CZP educational materials and to what extent those materials were read and understood.- A summary of correct responses to each question regarding CZP risks.