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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05909761
Other study ID # VIB0551.P4.S4
Secondary ID EUPAS105613
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2023
Est. completion date August 2032

Study information

Verified date April 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Acquired from Horizon in 2024.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
UPLIZNA
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.

Locations

Country Name City State
United States University of Colorado Denver Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

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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