Injectors’ Survey to Assess Effectiveness of BELKYRA Risk Minimisation Activities

Study identification

• EU PAS number:
  EUPAS24321
• Study ID:
  36555
• Official title and acronym:
  Injectors’ Survey to Assess Effectiveness of BELKYRA Risk Minimisation Activities
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Italy

  Lithuania

  Spain

  Sweden

  United Kingdom
• Study description:
  This study will assess HCPs understanding of the key safety messages of BELKYRA regarding injection site nerve injury and injection site skin ulceration as communicated in the Injector’s Guide for the Safe Use of BELKYRA.
• Study status:
  Finalised

Research institutions and networks

Institutions

CRO

Study timelines

Date when funding contract was signed

Planned:16/04/2018

Actual:16/04/2018

Study start date

Planned:01/06/2021

Actual:19/10/2021

Date of final study report

Planned:30/06/2024

Actual:18/07/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

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

CMO-EPI-FAS-0565