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 German Registry Rheumatoide Arthritis: Beobachtung der Biologika Therapie (RABBIT) (Safety of tofacitinib in RABBIT)

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:
  500

Study design details

• Main study objective:
  To evaluate the rates of serious infections, malignancy, CV, and other specified outcomes among patients with RA in a German register who initiate tofacitinib. Rates will also be estimated among existing cohorts of bDMARD and nbDMARD patients to provide context for rates observed on tofacitinib. No a priori hypotheses will be tested in this descriptive study
• Data analysis plan:
  The initial analyses will consist of descriptive comparisons of baseline status and crude event rates between the different cohorts. The final analysis of endpoints will provide the rates of events overall and in subgroups defined by baseline characteristics. Pending feasibility, rates of malignancy, serious infection, CV and other event rates will be compared between tofacitinib treated RA patients and the comparator cohorts using methods that adjust for sex, age, year of treatment start, treatment history, disease severity, comorbidities, and other potential confounders.

Documents

Study, other information

A3921317_PROTOCOL VERSION 3.0_14Feb2022