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Clinical Trials in the USA / NCT06126835
Active, not recruiting Observational

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

NCT06126835 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2024-08-26
Last updated
2024-10-01

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Ozanimod →Conventional therapyAdvanced therapy

Ozanimod: Women with UC exposed to ozanimod during pregnancy

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

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

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
49 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Prevalence of major congenital malformations among infants — 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.

Trial sites (1)

FacilityCityRegionStatus
OptumInsight Life Sciences Inc Eden Prairie Minnesota

More Bristol-Myers Squibb trials in the USA

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis Recruiting
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A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting

Other trials for the same condition

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Recruiting
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002) Recruiting
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Recruiting
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis Recruiting
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06126835 on ClinicalTrials.gov ↗ ← All trials in the USA