Non-Interventional Study to Review the Changes of Depression after First-Year of Tofacitinib Treatment in Rheumatoid Arthritis (XELJANZ®)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Single arm, prospective

Study drug and medical condition

• Name of medicine:
  Xeljanz
• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib
• Medical condition to be studied:
  Rheumatoid arthritis

  Depression

  Insomnia

  Anxiety

  Arthralgia

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:
  154

Study design details

• Main study objective:
  To describe and evaluate the changes of depression level within 12 months from the start of Tofacitinib therapy.
• Outcomes:
  - To find out if treatment by Tofacitinib reduces the depression by at least 10% during 12 months. ; - To describe and evaluate the level and changes of pain, anxiety and insomnia in patients with RA. ; - To describe the safety and effectiveness of Tofacitinib for the treatment of rheumatoid arthritis.
• Data analysis plan:
  Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a Statistical Analysis Plan (SAP). Unless specified otherwise, continuous variables will be summarized using descriptive statistics (n, mean, SD, median, min, max) and discrete variables will be summarized using counts and percentages. To access drop-out, study flow-chart (patient disposition) between visits will be preset.

Documents

Study, other information

A3921330_Abstract_18 June 2021