A prospective, non-interventional study in female patients with moderate to severe active rheumatoid arthritis in France receiving filgotinib for 2 years (PARROTFISH)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

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:
  150

Study design details

• Main study objective:
  To describe the treatment persistence rate at 24 months per routine practice, defined as the rate of patients continuing to receive filgotinib for approximately 24 months from treatment initiation.
• Outcomes:
  Treatment persistence rates at 24 months, Throughout the study: disease activity (DAS28CRP and/or CDAI), rates of AE and SAE during 24 months, patients' assessment of pain (Pain VAS), patients' assessment of fatigue (FACIT-F score), patients' assessment of work productivity (WPAI-RA), patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID).
• Data analysis plan:
  In general, for continuous variables, descriptive summary statistics will be provided including number of patients (N), mean, standard deviation (SD), minimum, median, and maximum, together with the number of missing values. Categorical variables will be summarized with counts and percentages, with missing values as separate category. Incidence rates and 95% confidence intervals (CIs) will be provided. Demographics and baseline characteristics will be summarized using descriptive statistics.