The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy (200870 NPSS (Nucala Pregnancy Surveillance Study))

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40792
• EU PAS number:
  EUPAS13772
• Study ID:
  40792
• Official title and acronym:
  The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy (200870 NPSS (Nucala Pregnancy Surveillance Study))
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  The Mepolizumab Pregnancy Exposure Study is a prospective, observational, exposure cohort study of pregnancy outcomes in women exposed to mepolizumab during pregnancy compared to pregnancy outcomes in women who have not used mepolizumab during pregnancy but have used other anti-asthmatic medications (treated disease comparison group), and pregnancy outcomes in women exposed to other non-teratogenic agents, (non-disease comparison group). The purpose of the study is to monitor planned and unplanned pregnancies exposed to mepolizumab and to evaluate the possible teratogenic effect of this medication relative to the primary pregnancy outcome of major birth defects and the secondary pregnancy outcomes of preterm delivery, small for gestational age infants and spontaneous abortion or stillbirth. The study is conducted by the Organization of Teratology Information Specialists (OTIS) Research Center located at the University of California, San Diego.
• Study status:
  Ongoing

Research institution and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

Networks

Organization of Teratology Information Specialists (OTIS) Network

American Academy of Asthma, Allergy and Immunology

Study timelines

Date when funding contract was signed

Planned: 20/09/2016

Actual: 20/09/2016

Study start date

Planned: 30/09/2016

Actual: 03/11/2016

Date of final study report

Planned: 30/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-200870-protocol-redact

Updated protocol

gsk-200870-protocol-redact-v02

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)