A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Overview
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
Primary outcome measures
- Major congenital malformations [Time frame: Up to first year of life]
Secondary outcome measures (12)
- Minor congenital malformations [Time frame: Up to first year of life]
- Pre-eclampsia [Time frame: Through pregnancy]
- Eclampsia [Time frame: Through pregnancy]
- Spontaneous abortion [Time frame: Through pregnancy]
- Stillbirth [Time frame: Through pregnancy]
- Elective termination [Time frame: Through pregnancy]
- Preterm birth [Time frame: Through pregnancy]
- Small for gestational age [Time frame: Up to first year of life]
- Postnatal growth deficiency [Time frame: Up to first year of life]
- Infant developmental deficiency [Time frame: Up to first year of life]
- Perinatal death [Time frame: Up to first year of life]
- Neonatal death [Time frame: Up to first year of life]
Eligibility criteria
Inclusion criteria
- Diagnosis of Multiple sclerosis (MS)
- Currently or recently pregnant
- Reside in the United States, Canada or Germany.
Exclusion criteria
- Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
Other protocol-defined inclusion/exclusion criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Evidera INC. — Bethesda
- Evidera — Bethesda
Germany · 1 center
- Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum — Herne
Identifiers
NCT: NCT05170126 · IM047-003