An Active Surveillance, Post Authorization Safety Study (PASS) of Serious Infection, Malignancy, Cardiovascular (CV) and Other Safety Events of Interest among Patients Treated with Tofacitinib for Moderately to Severely Active Rheumatoid Arthritis (RA) within the Swedish, Population based, Anti Rheumatic Treatment in Sweden (ARTIS) register. (Safety of tofacitinib in ARTIS)

Study type

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

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

• 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:
  344

Study design details

• Main study objective:
  To estimate the rates of serious infections, malignancy, CV and other safety events of interest among patients with RA in Sweden who initiate tofacitinib. Rates will also be estimated among RA patients who initiate biologic DMARDs (bDMARDs), bDMARD and targeted synthetic DMARD (tsDMARD) naïve RA patients, and the general population to provide context for tofacitinib rates.
• Data analysis plan:
  descriptive summaries of baseline variables and crude rates of safety event of interest included in ARTIS. An interim and final analysis of endpoints will describe the rates of events overall with supplemental linked data. Pending feasibility, comparative, adjusted analyses that control for sex, age, year of treatment start, treatment history, disease severity, comorbidities, and other potential confounders will be performed for a final report

Documents

Study, other information

A3921314_PROTOCOL VERSION 3.0_14Feb2022