A Study of Ozanimod in Pregnant Women With Ulcerative Colitis 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: Ulcerative Colitis. 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
- 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) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
Overview
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
Primary outcome measures
- Event rate of Major Congenital Malformations (MCM) [Time frame: Up to 12 months]
Secondary outcome measures (12)
- Event rate of minor congenital malformations [Time frame: Up to 12 months]
- Event rate of pre-eclampsia [Time frame: Up to 9 months]
- Event rate of eclampsia [Time frame: Up to 9 months]
- Event rate of Spontaneous Abortion (SAB) [Time frame: Up to 9 months]
- Event rate of stillbirth [Time frame: Up to 9 months]
- Event rate of elective termination [Time frame: Up to 9 months]
- Event rate of preterm birth [Time frame: Up to 9 months]
- Event rate of Small for Gestational Age (SGA) [Time frame: Up to 12 months]
- Event rate of postnatal growth deficiency [Time frame: Up to 12 months]
- Event rate of infant developmental deficiency [Time frame: Up to 12 months]
- Event rate of perinatal death [Time frame: Up to 10 months]
- Event rate of neonatal death [Time frame: Up to 1 month]
Eligibility criteria
Inclusion criteria
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
Exclusion criteria
- Exposure to other S1P therapies at any time during pregnancy
Other protocol-defined eligibility criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- PPD Virtual - PPD - US — Wilmington
Identifiers
NCT: NCT05953402 · IM047-026