Subcutaneous Interferon beta therapy in multiple sclerosis patients and characterization of injection site reactions and flu-like symptoms under daily practice setting (PERFECT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36739
• EU PAS number:
  EUPAS21013
• Study ID:
  36739
• Official title and acronym:
  Subcutaneous Interferon beta therapy in multiple sclerosis patients and characterization of injection site reactions and flu-like symptoms under daily practice setting (PERFECT)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms (FLS) as reported by the relapsing-remitting multiple sclerosis (RRMS) participants.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 54 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/12/2017

Actual: 31/12/2017

Study start date

Planned: 31/12/2017

Actual: 16/11/2017

Data analysis start date

Planned: 30/08/2019

Date of final study report

Planned: 31/12/2019

Actual: 16/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

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

GER-PEG-16-10988