Evaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid arthritis in a sample of European Economic Area countries

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Healthcare professional survey, patient survey and retrospective chart review study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ABATACEPT
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Patients with rheumatoid arthritis and rheumatologists/nurses.
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The main objective of the study is to evaluate the effectiveness of the abatacept PACs by:1. Assessment of the distribution, awareness, utilisation, utility, knowledge, comprehension and behaviour by patients and HCPs.2. Correlation of measures of the distribution, awareness, utilisation, utility, k
• Outcomes:
  Patient survey: proportion of correct responses to individual questions about receipt, knowledge, understanding and acting on the advice contained in the abatacept PACs.HCP survey: proportion of correct responses to individual questions about understanding and mplementation of key messages contained in the abatacept PACs.Outcomes evaluation: proportion of infections leading to hospitalization. Patient survey:determinants of patient knowledge and understanding and implementation of the key messages.HCP survey:determinants of HCP understanding and implementation regarding key messages.Outcomes:mean time from infection to medical attention, proportion of: patients with results of tests to screen for tuberculosis/viral hepatits, emergency room visits, umplanned hospitalisation.
• Data analysis plan:
  For the patient and HCP questionnaires, the percentage of patients/HCPs with responses to each question that indicate effectiveness of the PAC will be determined: receipt, awareness, usage, knowledge and comprehension of key messages. The primary endpoints of the patient survey responses indicating understanding and implementation will be analysed by baseline patient characteristics. The primary endpoints of the HCP survey responses indicating understanding and implementation of the PACs will be analysed by baseline HCP characteristics. Correlation between patients’ degree of understanding and implementation of the messages in the PACs with infections leading to hospitalisation and with other secondary endpoints will be studied through regression techniques.

Documents

Study results

IM101537Orencia_FSR Abstract_v1.0_07Sep2017