Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program (POP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48914
• EU PAS number:
  EUPAS27459
• Study ID:
  48914
• Official title and acronym:
  Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program (POP)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Canada

  Denmark

  France

  Germany

  Ireland

  Italy

  Netherlands

  Portugal

  Spain

  Switzerland

  United Kingdom

  United States
• Study description:
  The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice, to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice, to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation, to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS), to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 172 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 28/08/2013

Study start date

Actual: 12/11/2014

Date of final study report

Planned: 14/06/2022

Actual: 01/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

105MS401 Protocol V5 Final 16Apr2019_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

105MS401,,NCT02230969: https://clinicaltrials.gov/ct2/show/NCT02230969