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 topic:
  Human medicinal product
• 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

• Study design:
  DUS using a non-interventional follow-up (cohort) design with secondary use of data ; collected from 5 European rheumatology registries (from DK, GE, ES, SW, and the UK). The study was requested by the PRAC and fulfills the criteria of a non-interventional PASS.
• Main study objective:
  The purpose of this non-interventional PASS requested by the PRAC, is to examine the characteristics of patients under filgotinib treatment in terms of prevalence of risk factors for MACE, malignancy, VTE, and serious and opportunistic infections, to evaluate whether the appropriate initial dose of filgotinib is being prescribed (e.g., 100 mg/day in patients aged over 65-years-of-age and older), whether contraindications are adhered to (e.g., no administration in pregnant women and discontinuation in women who become pregnant during the treatment; administration), and to evaluate treatment changes following an event of concern (e.g., discontinuation following a VTE episode).
• 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.