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.
Acquired from Horizon in 2024.
Study Type
OBSERVATIONAL
Enrollment
60
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
University of Colorado Denver
Aurora, Colorado, United States
RECRUITINGNumber of newborns with Major Congenital Malformations (MCMs)
Time frame: Minimum of 10 years
Number of newborns with Preterm birth
Time frame: Minimum of 10 years
Number of newborns with low birth weight
Time frame: Minimum of 10 years
Number of stillbirths
Time frame: Minimum of 10 years
Number of newborns with Minor Congenital Malformations
Time frame: Minimum of 10 years
Number of infants with developmental milestone abnormalities
Time frame: Minimum of 10 years
Number of infants with neurologic abnormalities
Time frame: Minimum of 10 years
Number of infants with immune system development abnormalities
Time frame: Minimum of 10 years
Number of Spontaneous Abortions
Time frame: Minimum of 10 years
Number of Induced or Elective Abortions
Time frame: Minimum of 10 years
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