Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
What it found
No result yet.
What was tested
Treatment tested
- Inebilizumab
B-lymphocyte antigen CD19 binding agent
What it measured
Main measures
Number of newborns with Major Congenital Malformations (MCMs)
Minimum of 10 years
Number of newborns with Preterm birth
Minimum of 10 years
Number of newborns with low birth weight
Minimum of 10 years
Number of stillbirths
Minimum of 10 years
Other measures (6)
Number of newborns with Minor Congenital Malformations
Minimum of 10 years
Number of infants with developmental milestone abnormalities
Minimum of 10 years
Number of infants with neurologic abnormalities
Minimum of 10 years
Number of infants with immune system development abnormalities
Minimum of 10 years
Number of Spontaneous Abortions
Minimum of 10 years
Number of Induced or Elective Abortions
Minimum of 10 years
Who could take part
NMOSD · 15 and over
Inclusion Criteria: * Provide informed consent * Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD * Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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No result found
History
Started
Jan 2027
Main results due
Oct 2032
Finished
Oct 2032
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