Pregnancy Related Clinical Trial
Official title:
An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
Verified date | April 2024 |
Source | Amgen |
Contact | Amgen Call Center |
Phone | 866-572-6436 |
medinfo[@]amgen.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 2032 |
Est. primary completion date | August 2032 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of newborns with Major Congenital Malformations (MCMs) | Minimum of 10 years | ||
Primary | Number of newborns with Preterm birth | Minimum of 10 years | ||
Primary | Number of newborns with low birth weight | Minimum of 10 years | ||
Primary | Number of stillbirths | Minimum of 10 years | ||
Secondary | Number of newborns with Minor Congenital Malformations | Minimum of 10 years | ||
Secondary | Number of infants with developmental milestone abnormalities | Minimum of 10 years | ||
Secondary | Number of infants with neurologic abnormalities | Minimum of 10 years | ||
Secondary | Number of infants with immune system development abnormalities | Minimum of 10 years | ||
Secondary | Number of Spontaneous Abortions | Minimum of 10 years | ||
Secondary | Number of Induced or Elective Abortions | Minimum of 10 years |
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