Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48161
• EU PAS number:
  EUPAS3976
• Study ID:
  48161
• Official title and acronym:
  Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Canada

  France

  Germany

  Ireland

  Italy

  Poland

  Spain

  United Kingdom

  United States
• Study description:
  The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate and and peginterferon beta-1a. The secondary objective is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapy (DMTs).
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 17 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 03/06/2013

Actual: 21/06/2013

Study start date

Planned: 03/06/2013

Actual: 30/10/2013

Date of final study report

Planned: 18/07/2029

Actual: 18/01/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

109MS402 EU V5 Protocol_Redacted

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)

Other study registration identification numbers and links

109MS402 NCT01911767 https://clinicaltrials.gov/ct2/show/NCT01911767?term=109ms402&rank=1