Full name

bMUM: The Belimumab and Lupus Pregnancy Exposure Study

NCT Number
GSK Study ID: 213928
Primary Endpoints

Primary:

  • Number of live birth pregnancies with major birth defect among pregnancies with at least one live births. At birth or up to 1 year of age

Secondary:

  • Number of pregnant women who had spontaneous abortion. Up to 20 weeks gestation
  • Number of pregnant women who had stillbirth. At birth
  • Number of pregnant women who had elective termination of pregnancy. During Pregnancy (Up to 36 weeks)
  • Number of pregnant women who had preterm delivery. At birth
  • Number of infants categorized as Small for Gestational Age (SGA) at birth
  • Number of infants with minor birth defect pattern. From birth up to 1 year of age
  • Number of infants with post-natal growth deficiency. From birth up to 1 year of age
  • Number of infants with developmental concerns. At 1 year of age
  • Number of infants with serious infections. From birth up to 1 year of age
External Link
https://www.gsk-studyregister.com/en/trial-details/?id=213928
Order
3
Disease
SLE
Menu title
bMUM: The Belimumab and Lupus Pregnancy Exposure Study
Version
ASN 2025
Phase
Observational
QR code description
Scan QR Code to view the Study Summary on the GSK Study Register
Status
Recruiting
Compound name
Belimumab
Unmet Burden Fact
  • There is a higher prevalence of SLE in women compared to men; the female-to-male ratio in the childbearing years has been reported to be as high as 12:1. In women, SLE typically develops between ages 15 and 44 years
Unmet Burden Fact Reference

Danchenko et al. Lupus. 2006;15(5):308-18

Study Description

The bMUM study is an observational study to monitor planned and unplanned pregnancies exposed to belimumab and to determine whether there is a signal for belimumab teratogenicity when compared to the background rate in an unexposed Systemic Lupus Erythematosus (SLE) cohort.