Non-interventional post-authorization cohort safety study evaluating the effectiveness of the additional risk minimization measures for filgotinib (Jyseleca®) use in patients with moderate to severe active rheumatoid arthritis within European registries

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Additional Risk Management Measures assessment

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FILGOTINIB MALEATE
• 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 assess the Health Care Professional (HCP) adherence with the Summary of Product Characteristics (SmPC) and the HCP Guide (i.e. avoidance of contraindicated populations and use of screening prior to administration of filgotinib) and to estimate the proportion of filgotinib users being at high risk
• Data analysis plan:
  Data from this non-interventional study will be summarized using univariate descriptive statistical methods. The number and proportion of users of filgotinib will be estimated among several subgroups of relevance at treatment initiation and follow up, as per the objectives of the study. Categorical variables will be summarized by number and percentage of patients in each categorical definition and include 95% CIs. Counts for missing values will be also tabulated but missing values will not be considered in the percentages. Continuous variables will be summarized descriptively (mean, standard deviation, and median, lower quartile, upper quartile, minimum, maximum, 95% CIs). Detailed methodology for the analyses of data included in this study will be documented in the statistical analysis plan, which will be created by the investigators from the 5 registries, dated, filed, and archived by the MAH.