An Observational, Post-Authorization Safety Study (PASS) within the Consortium of Rheumatology Researchers of North America (CORRONA) Registry ComparingRates of Malignancy, Cardiovascular and Serious Infection Outcomes among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis (CORRONA Surveillance PASS)

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

• Name of medicine:
  XELJANZ
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  All patients, 18 years of age and older, who receive tofacitinib for the treatment of RA following US approval and marketing through the end of the study period (estimated to be 5 years from the launch date). Incident and prevalent users of tofacitinib were included.
• 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:
  Other
• Special population of interest, other:
  Rheumatoid arthritis patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The main objective of the study is to assess the safety of tofacitinb in the post-approval setting.
• Outcomes:
  The primary outcomes are serious infections, malignancies and cardiovascular events. Secondary outcomes include events commonly seen in patients with RA.
• Data analysis plan:
  For the safety endpoints of interest, summary statistics, frequencies, crude cumulative incidence proportions, and crude incidence rates (ie, number of events per person-years) and associated 95% confidence intervals will be calculated as appropriate. Depending on data availability, subgroupanalyses may be performed.

Documents

Study results

a3921205-report-body