International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis (OBS13436)

Study identification

• EU PAS number:
  EUPAS7574
• Study ID:
  50049
• Official title and acronym:
  International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis (OBS13436)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Canada

  Denmark

  Germany

  Italy

  Netherlands

  Spain

  Sweden

  Switzerland

  United Kingdom

  United States
• Study description:
  A voluntary post authorization safety study (PASS). An international, prospective, observational cohort study (registry) of pregnancy outcomes in women with multiple sclerosis exposed to LEMTRADA during pregnancy. The overall goal of the study is to evaluate pregnancy outcomes in women exposed to LEMTRADA during pregnancy and to determine if the risk of any adverse pregnancy outcomes in these women exceeds the risks in women with MS who have not been exposed to LEMTRADA during pregnancy. Specific outcomes to be assessed include: spontaneous abortion, stillbirth, fetal major malformations, preterm birth, and small for gestational age at birth. To further characterize prenatally-exposed live births, outcomes in the neonatal and pediatric periods up to one year of age will be assessed pending available data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned:08/09/2014

Actual:08/09/2014

Study start date

Planned:30/11/2014

Actual:01/09/2015

Date of final study report

Planned:04/11/2022

Actual:09/11/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Genzyme a Sanofi Company

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)