Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Dupuytren’s contracture - a non-interventional post-authorization safety study

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Physicians survey, Post-authorization safety study

Study drug and medical condition

• Medicinal product name:
  XIAPEX
• Medical condition to be studied:
  Dupuytren's contracture

Population studied

• Short description of the study population:
  Physicians that have registering in the MAH’s Dupuytren’s Trained Physicians database and that are working in countries where Xiapex was launched after Dec -2016. Only those physicians who have been appropriately trained in the usage of Xiapex® in the treatment of Dupuytren’s contracture shall use Xiapex.
• 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:
  16

Study design details

• Main study objective:
  The main objective of this study is to evaluate the effectiveness of the educational material in knowledge transfer of important safety information to the treating physician
• Data analysis plan:
  The primary analysis set will consist of all physicians who have submitted the "Dupuytren’s contracture” survey.The primary endpoint, the correctness (yes, no) of answers to each of the 11 knowledge transfer questions, will be summarized descriptively.Missing data will be summarized descriptively.