Myozyme (alglucosidase alfa) Safety Information Packet effectiveness evaluation: a health care professional survey

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49116
• EU PAS number:
  EUPAS10301
• Study ID:
  49116
• Official title and acronym:
  Myozyme (alglucosidase alfa) Safety Information Packet effectiveness evaluation: a health care professional survey
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Poland

  Spain

  United Kingdom
• Study description:
  The Pharmacovigilance Risk Assessment Committee (PRAC) requested Genzyme, a Sanofi Company to further update the Myozyme Safety Information Packet (SIP) and to propose a study to evaluate the effectiveness of the updated version of the SIP. To comply with PRAC requirements, a health care professional survey that assesses the effectiveness of the updated SIP is proposed. The survey consists of two waves (wave 1 and wave 2) which are to be carried out pre- and post-implementation of the updated SIP, at least 18 months apart. The survey is intended to assess whether implementation of the updated SIP has led to increased awareness, usage, usefulness, readability, understanding, clinical knowledge and behavioural implementation of key safety messages compared with the previous version of the SIP. Distribution and opinion of HCPs about the SIP will also be evaluated.
• Study status:
  Finalised

Research institution and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 09/12/2014

Actual: 09/12/2014

Study start date

Planned: 01/05/2015

Actual: 17/06/2015

Date of interim report, if expected

Planned: 20/09/2015

Actual: 14/09/2015

Date of final study report

Planned: 08/03/2017

Actual: 31/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Genzyme Europe B.V., The Netherlands.

Study protocol

Initial protocol

Myozyme HCP Survey_Protocol_V3-2_(30Jan2015)

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)