Post-marketing Study Assessing the Long-term Safety of Abatacept

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cohort

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 risk of malignancies and infections among a cohort of rheumatoid arthritis (RA) patients who are prescribed abatacept and a cohort of patients who were prescribed other RA treatments.
• 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:
  Rheumatoid arthritis patients
• Estimated number of subjects:
  140000

Study design details

• Main study objective:
  To estimate and compare the risk of malignancies and infections among a cohort of RA patients whoare prescribed abatacept and a cohort of patients who are prescribed other RA treatments.
• Outcomes:
  Primary outcomes of interest include lung cancer, lymphoma, breast cancer, non-melanoma skin cancer, all malignancies, hospitalized infections, pneumonia, opportunistic infections and tuberculosis. lupus, multiple sclerosis and psoriasis
• Data analysis plan:
  Descriptive analyses of the data will be conducted. Overall incidence rates and rates stratified by age group and sex will be calculated. Unadjusted and adjusted Cox proportional hazards regression analyses will be performed.