A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorBristol-Myers Squibb
About this trial
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently or recently pregnant
Diagnosis of UC
Resident of country where ozanimod is prescribed for the treatment of UC
Disqualifiers
Exposure to other S1P therapies at any time during pregnancy
Trial population
The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,182 Participants
are grouped into 3 trial groupsGroup A: Ozanimod-exposed participants with UC
Group B: Conventional therapy-exposed participants with UC
Group C: Advanced therapy-exposed participants with UC
Trial outcomes
Primary outcomes
1
Event rate of Major Congenital Malformations (MCM)
Time frame
Up to 12 monthsSecondary outcomes
1
Event rate of minor congenital malformations
Time frame
Up to 12 months2
Event rate of pre-eclampsia
Time frame
Up to 9 months3
Event rate of eclampsia
Time frame
Up to 9 months4
Event rate of Spontaneous Abortion (SAB)
Time frame
Up to 9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov