A Survey of Healthcare Professionals in Europe to Evaluate the Effectiveness of the ENJAYMO™ Physician’s Guide

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000209
• EU PAS number:
  EUPAS1000000209
• Study ID:
  1000000209
• Official title and acronym:
  A Survey of Healthcare Professionals in Europe to Evaluate the Effectiveness of the ENJAYMO™ Physician’s Guide
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Netherlands
• Study description:
  This is a multinational, non-interventional, cross sectional survey study to evaluate the effectiveness of the ENJAYMO™ Physician’s Guide among EEA-based HCPs.; ; The current study is planned to be conducted among HCPs in countries in the EEA where the product is expected to be commercially available for at least 6 months. The survey will be launched no sooner than 6 months, and no longer than 18 months, after the ENJAYMO™ Physician’s Guide has been disseminated in each participating country. The survey may be conducted in up to 2 waves with the second wave of the same survey opening 6 to 12 months after the first wave is closed.; ; The survey is anticipated to be open between 3 to 6 months per country per wave. Depending on response rates, follow-up reminders will be sent to non-respondents to endeavor to achieve the target sample size, and the medical scientific liaison team of Sanofi could also be involved in some countries to advocate via their personal contacts the participation to the survey for HCPs already contacted via e-mail. In the event that less than 30 completed surveys are achieved in the first wave of the study, a second wave of the same survey will be triggered.; ; Data will be collected by web-based electronic data capture. Information collected will include the receipt and reading of the ENJAYMO™ Physician’s Guide, knowledge of the key information included in the ENJAYMO™ Physician’s Guide, the impact of the ENJAYMO™ Physician’s Guide on clinical action, and HCP characteristics.
• Study status:
  Ongoing

Research institution and networks

Institutions

Sanofi

ICON Commersialisation & Outcomes (MAPI-ICON), ICON

Germany

Study timelines

Date when funding contract was signed

Planned: 28/06/2021

Actual: 28/06/2021

Study start date

Planned: 07/03/2022

Actual: 07/03/2022

Data analysis start date

Planned: 31/10/2025

Date of final study report

Planned: 03/02/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Genzyme Europe BV

Study protocol

Updated protocol

Sanofi ENJAYMO Survey Protocol__v2.0_05Jun2024_redactedd.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

Protocol number: CEF-0205