clinical trial · NCT06126835
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
Bristol-Myers Squibb·—·active not recruiting·n = 2,828
Ulcerative ColitisOzanimodConventional therapyAdvanced therapy
brief 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.
started
Aug 26, 2024
primary completion
May 31, 2031
completion
Jun 30, 2032
last updated
Oct 1, 2024
official title
Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol