ENSTILAR RWE STUDY, IN FRENCH EMR DATABASE (THIN®)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50586
• EU PAS number:
  EUPAS50585
• Study ID:
  50586
• Official title and acronym:
  ENSTILAR RWE STUDY, IN FRENCH EMR DATABASE (THIN®)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The research aim of this project is to better understand the utilization of Enstilar®, compared to Daivobet®, according to patient profile and treatment pathway and outcomes. A second objective is to characterize the Enstilar® prescription for “beyond mild” patients in France. This translates into a primary objective being to describe and compare profiles of patients who received Enstilar® and/or Daivobet®. The secondary objective is to describe, through a follow-up period, the treatment pathway and health resource utilization (HRU) for patients prescribed Enstilar® compared to Daivobet®. The research aim of this project is to better understand the utilization of Enstilar®, compared to Daivobet®, according to patient profile and treatment pathway and outcomes. A second objective is to characterize the Enstilar® prescription for “beyond mild” patients in France. This translates into a primary objective being to describe and compare profiles of patients who received Enstilar® and/or Daivobet®. The secondary objective is to describe, through a follow-up period, the treatment pathway and health resource utilization (HRU) for patients prescribed Enstilar® compared to Daivobet®.
• Study status:
  Finalised

Research institutions and networks

Institutions

Cegedim Health Data (CHD)

France

Study timelines

Date when funding contract was signed

Actual: 24/11/2021

Study start date

Actual: 30/05/2022

Data analysis start date

Actual: 04/07/2022

Date of final study report

Actual: 13/01/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LEO Pharma

Study protocol

Initial protocol

Leo_Cegedim_Enstilar RWE protocol_Final may 2022

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable