A prospective, non-interventional study of the effectiveness, safety, and health related outcomes in patients with moderate to severe active rheumatoid arthritis receiving filgotinib (FILOSOPHY)

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:
  1304

Study design details

• Main study objective:
  To evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation.
• Outcomes:
  Treatment persistence rates at 24 months, Throughout the study: 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), disease activity (DAS28CRP and/or CDAI), medication adherence (CQR19 and CQR5), 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.