Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49260
• EU PAS number:
  EUPAS38347
• Study ID:
  49260
• Official title and acronym:
  Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support Program
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the German Patient Support Program (PSP) and of whom a pregnancy report and pregnancy outcome report is available. The secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Planned: 26/10/2020

Actual: 09/12/2020

Study start date

Planned: 30/04/2021

Actual: 01/05/2021

Date of final study report

Planned: 15/12/2021

Actual: 08/07/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

PRIMA_Phase 4 Observational PASS Protocol_V1.0_final_20201007_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

DE-PEG-11650