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NCT Number: NCT06126835

A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis 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 ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy 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

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal 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

  • Age 18 to 49 years on date of conception
  • Date of conception between June 1, 2021 and September 1, 2030
  • Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
  • Diagnosis of UC during the 12 months prior to conception through the end of the first trimester

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)

Treatment and study plan

Ozanimod

Drug

Women with UC exposed to ozanimod during pregnancy

Conventional therapy

Drug

Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy

Advanced therapy

Drug

Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy

Primary outcomes

  1. Prevalence of major congenital malformations among infants

    Time frame: Up to 10 years

    To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.

Secondary outcomes

  1. Number of spontaneous abortions

    Time frame: Up to 10 years

  2. Number of stillbirths

    Time frame: Up to 10 years

  3. Number of participants with pre-eclampsia

    Time frame: Up to 10 years

  4. Number of participants with eclampsia

    Time frame: Up to 10 years

  5. Number of preterm births

    Time frame: Up to 10 years

  6. Number of infants small for gestational age

    Time frame: Up to 10 years

  7. Number of serious or opportunistic infections in liveborn infants up to 1 year of age

    Time frame: Up to 10 years

  8. Number of infant postnatal growth deficiencies

    Time frame: Up to 10 years

  9. Number of infant developmental deficiencies

    Time frame: Up to 10 years

  10. Number of neonatal hospitalizations

    Time frame: Up to 10 years

  11. Number of infant deaths

    Time frame: Up to 10 years

  12. Number of neonatal deaths

    Time frame: Up to 10 years

  13. Number of perinatal deaths

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring

Important dates

Study start
2024
Primary completion
2031
Study completion
2032
First posted
Nov 13, 2023
Registry last updated
Oct 1, 2024

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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