Drug Utilization Study of ZALTRAP® (aflibercept) Using European Databases (Zaltrap Utilization Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16787
• EU PAS number:
  EUPAS5365
• Study ID:
  16787
• Official title and acronym:
  Drug Utilization Study of ZALTRAP® (aflibercept) Using European Databases (Zaltrap Utilization Study)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  During the registration application with EMA for aflibercept to be marketed in the EU, Sanofi proposed a three-year drug utlization study (DUS) using European databases as part of the post-approval commitments. The primary objectives of the proposed DUS are to monitor ZALTRAP use in cancer patients including potential off-label use and evaluate the potential for intravitreal use.
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Evidence Solutions, IMS Health

France

Study timelines

Date when funding contract was signed

Planned: 30/08/2013

Actual: 16/10/2013

Study start date

Planned: 01/01/2013

Actual: 01/01/2013

Data analysis start date

Planned: 02/06/2014

Actual: 02/06/2014

Date of interim report, if expected

Planned: 30/11/2014

Actual: 30/11/2014

Date of final study report

Planned: 30/11/2016

Actual: 30/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

Zaltrap DUS Protocol Final_revision

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)