Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) exposed to UPLIZNA® during pregnancy
Study Details
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.
Protocol Summary
Number of newborns with Major Congenital Malformations (MCMs)
Timeframe: Minimum of 10 years
Number of newborns with Preterm birth
Timeframe: Minimum of 10 years
Number of newborns with low birth weight
Timeframe: Minimum of 10 years
Number of stillbirths
Timeframe: Minimum of 10 years
Number of newborns with Minor Congenital Malformations
Timeframe: Minimum of 10 years
Number of infants with developmental milestone abnormalities
Timeframe: Minimum of 10 years
Number of infants with neurologic abnormalities
Timeframe: Minimum of 10 years
Number of infants with immune system development abnormalities
Timeframe: Minimum of 10 years
Number of Spontaneous Abortions
Timeframe: Minimum of 10 years
Number of Induced or Elective Abortions
Timeframe: Minimum of 10 years