Atopic Dermatitis – Treatment Response EVALuation and UsEr Satisfaction with Tralokinumab in Standard Clinical Practice (ADValue)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Other
• If ‘other’, further details on the scope of the study:
  Efficacy and safety study with no comparator
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  A non-interventional, non-comparative, prospective, observational study with primary data collection in routine clinical practice.

Study drug and medical condition

• Medicinal product name:
  ADTRALZA
• Study drug International non-proprietary name (INN) or common name:
  TRALOKINUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH07) tralokinumab

  tralokinumab
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• Short description of the study population:
  Adolescent (12 years and older) and adult patients with moderate-to-severe AD, eligible for treatment with tralokinumab (new users), during routine clinical care. The decision to start treatment in a patient with tralokinumab was taken before and independently of enrolment in the study.
• Age groups:
  • Adolescents (12 to < 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:
  400