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NCT Number: NCT06133049

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants

The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

OptumInsight Life Sciences Inc

Eden Prairie, Minnesota, 55344, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 to 49 years at date of conception
  • Date of conception between April 1, 2020 and July 31, 2030

Exclusion criteria

  • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
  • Exposure to the DMTs fingolimod, siponimod, mitoxantrone, and teriflunomide within a period of 5 half-lives prior to the estimated date of conception through the end of the first trimester

Treatment and study plan

Ozanimod

Drug

Women with MS who were exposed to ozanimod during pregnancy

Select DMTs other than ozanimod

Drug

Women with MS exposed to select DMTs other than ozanimod during pregnancy

No DMTs

Drug

Women with MS not exposed to any DMTs during pregnancy

Primary outcomes

  1. Prevalence of major congenital malformations among infants

    Time frame: Up to 11 years

    Prevalence of major congenital malformations among infants born to women with MS exposed to ozanimod during the first trimester, and to compare this to the prevalence among each of the two comparator groups of pregnant women (other DMT exposed or NO DMT exposed)

Secondary outcomes

  1. Number of spontaneous abortions

    Time frame: Up to 11 years

  2. Number of preterm births

    Time frame: Up to 11 years

  3. Number of stillbirths

    Time frame: Up to 11 years

  4. Number of participants with pre-eclampsia

    Time frame: Up to 11 years

  5. Number of participants with eclampsia

    Time frame: Up to 11 years

  6. Number of infants small for gestational age

    Time frame: Up to 11 years

  7. Number of serious or opportunistic infections in liveborn infants up to one year of age

    Time frame: Up to 11 years

  8. Number of infant postnatal growth deficiencies

    Time frame: Up to 11 years

  9. Number of infant developmental deficiencies

    Time frame: Up to 11 years

  10. Number of neonatal hospitalizations

    Time frame: Up to 11 years

  11. Number of infant deaths

    Time frame: Up to 11 years

  12. Number of neonatal deaths

    Time frame: Up to 11 years

  13. Number of perinatal deaths

    Time frame: Up to 11 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Nov 15, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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