Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Conditions
Keywords
Neuromyelitis Optica Spectrum Disorder, Pregnancy, UPLIZNA, inebilizumab, birth complications
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.
Interventions
DRUGUPLIZNA
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed