Real World Use, Effectiveness and Safety of Teprotumumab among Thyroid Eye Disease Patients treated in China BOAO Pilot Zone: A Retrospective Cohort Study (20240345)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Teprotumumab (TEPEZZA®)
• Study drug International non-proprietary name (INN) or common name:
  TEPROTUMUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG13) teprotumumab

  teprotumumab
• Medical condition to be studied:
  Graves' disease
• Additional medical condition(s):
  thyroid eye disease

Population studied

• Age groups:
  • 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:
  10

Study design details

• Main study objective:
  The main objective of this study is to assess proportion of patients with proptosis response as of; last intravenous infusion of teprotumumab.
• Outcomes:
  Secondary endpoints; - Baseline characteristics; - Teprotumumab use; - Proptosis; - Clinical Activity Score ; - Diplopia; - Quality of life; - The incidence of adverse events between the administration of the first dose and 30 days after the last dose of teprotumumab; - Status of AE of interest up to 6 months after last infusion of teprotumumab
• Data analysis plan:
  All analyses will be descriptive in nature.