- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05909761
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
April 24, 2024 updated by: Horizon Therapeutics Ireland DAC
An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Medical Monitor
- Phone Number: 1-866-479-6742
- Email: clinicaltrials@horizontherapeutics.com
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Denver
-
Contact:
- Amanda Piquet, MD
- Phone Number: 303-724-4319
- Email: AMANDA.PIQUET@CUANSCHUTZ.EDU
-
Principal Investigator:
- Dr. Amanda Piquet, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of participants who have been exposed to UPLIZNA during pregnancy and have signed an informed consent form (ICF).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of newborns with Major Congenital Malformations (MCMs)
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of newborns with Preterm birth
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of newborns with low birth weight
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of stillbirths
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of newborns with Minor Congenital Malformations
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of infants with developmental milestone abnormalities
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of infants with neurologic abnormalities
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of infants with immune system development abnormalities
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of Spontaneous Abortions
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Number of Induced or Elective Abortions
Time Frame: Minimum of 10 years
|
Minimum of 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2023
Primary Completion (Estimated)
August 1, 2032
Study Completion (Estimated)
August 1, 2032
Study Registration Dates
First Submitted
June 9, 2023
First Submitted That Met QC Criteria
June 9, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIB0551.P4.S4
- EUPAS105613 (Other Identifier: European Union Post Authorization Studies)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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