An Active Surveillance, Post Authorization Safety Study (PASS) to Estimate Incidence Rates of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among all Patients Treated with Ruxience for Rheumatoid Arthritis (RA) within the Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) Register

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  RUXIENCE
• Study drug International non-proprietary name (INN) or common name:
  RITUXIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC02) rituximab

  rituximab
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• 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:
  Pregnant women
• Estimated number of subjects:
  75

Study design details

• Main study objective:
  To estimate incidence rates of infections, including serious infections, malignancies, cardiovascular events, use during pregnancy among patients with rheumatoid arthritis in the ARTIS register who initiate Ruxience.
• Data analysis plan:
  Descriptive summaries of Ruxience exposed patients and crude incidence rates and 95% confidence intervals of safety event of interest.