Retrospective chart review to assess the effectiveness of the Skilarence® risk minimisation activities in daily practice – a post-authorisation safety study (PASS) (RETROSKIL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37187
• EU PAS number:
  EUPAS29842
• Study ID:
  37187
• Official title and acronym:
  Retrospective chart review to assess the effectiveness of the Skilarence® risk minimisation activities in daily practice – a post-authorisation safety study (PASS) (RETROSKIL)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  The aim of this PASS is to assess the effectiveness of risk minimisation measures for Skilarence® in daily clinical practice. The Summary of Product Characteristics (SmPC) and an educational programme aim to inform health care professionals about the risk of serious opportunistic infections such as progressive multifocal leukoencephalopathy (PML), associated with the use of Skilarence® and to provide guidance on how to minimise and manage this risk through appropriate monitoring of lymphocyte and leukocyte count abnormalities.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 15/06/2018

Actual: 15/06/2018

Study start date

Planned: 30/06/2019

Actual: 23/03/2021

Data analysis start date

Actual: 23/12/2021

Date of final study report

Planned: 31/12/2020

Actual: 15/12/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Almirall S.A

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)