An International Pregnancy Exposure registry of Women With Multiple Sclerosis (MS) exposed to Teriflunomide (OBS12751)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43003
• EU PAS number:
  EUPAS5602
• Study ID:
  43003
• Official title and acronym:
  An International Pregnancy Exposure registry of Women With Multiple Sclerosis (MS) exposed to Teriflunomide (OBS12751)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Denmark

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Netherlands

  Norway

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This is a voluntary, international, prospective, observational, non-interventional, exposure registration study examining the risk of major congenital malformations (birth defects) among the infants and fetuses of women with MS who are exposed to teriflunomide during pregnancy. The birth defect rate will be compared to published birth defect rates from the EUROCAT (EUROCAT, 2013).
• Study status:
  Finalised

Research institutions and networks

Institutions

Syneos Health

United Kingdom

INC Research

Study timelines

Date when funding contract was signed

Planned: 28/06/2013

Actual: 28/06/2013

Study start date

Planned: 31/01/2015

Actual: 25/11/2015

Date of final study report

Planned: 30/09/2023

Actual: 31/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

rdct-obs12751-amended-protocol03-pdfa

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)