Depicting real-life treatment journeys for patients affected with an immune-inflammatory condition and treated with methotrexate

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METHOTREXATE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX03) methotrexate

  methotrexate
• Additional medical condition(s):
  Immune-inflammatory condition

Population studied

• Short description of the study population:
  Patient will be included if they are suspected to be affected by one of the following condition: rheumatoid arthritis, psoriasis, psoriatic arthritis, systemic lupus erythematosus and juvenile idiopathic arthritis. In addition, patients have to receive at least one methotrexate injection.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The main objective of this study is to provide a depiction of patient-level treatment journeys of autoimmune patients.
• Data analysis plan:
  Scienta Lab will will analyse treatment journey of autoimmune patients using clinical and biological information. The results will be published in a peer-reviewed publications. Practice and patients' confidentiality will be maintained at any step of the study. Internal processes to ensure data safety and integrity are documented and have been shared with the data provider.