A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ORENCIA
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

Population studied

• 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:
  4000

Study design details

• Main study objective:
  The objective of this study is to determine the incidences of overall malignancies, melanoma, non-melanoma skin cancer, basal cell carcinoma, and squamous cell carcinoma in RA and PsA patients enrolled in the SRQ Register and who are receiving abatacept compared to patients who are receiving non-targeted DMARDs and compared to patients receiving targeted DMARDs.
• Outcomes:
  Overall malignancies, melanoma, non-melanoma skin cancer, basal cell carcinoma, and squamous cell carcinoma
• Data analysis plan:
  Analyses of rates of specified malignancy outcomes - incidence and hazard ratio considering comparators.