An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Sponsor
- Amgen
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of newborns with Major Congenital Malformations (MCMs)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
Acquired from Horizon in 2024.
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Number of newborns with Major Congenital Malformations (MCMs)
Time Frame: Minimum of 10 years
Number of stillbirths
Time Frame: Minimum of 10 years
Number of newborns with low birth weight
Time Frame: Minimum of 10 years
Number of newborns with Preterm birth
Time Frame: Minimum of 10 years
Secondary Outcomes
- 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 Induced or Elective Abortions(Minimum of 10 years)
- Number of Spontaneous Abortions(Minimum of 10 years)
- Number of infants with immune system development abnormalities(Minimum of 10 years)