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

Active, not recruitingOBSERVATIONAL
Enrollment

2,828

Participants

Timeline

Start Date

August 26, 2024

Primary Completion Date

May 31, 2031

Study Completion Date

June 30, 2032

Conditions
Ulcerative Colitis
Interventions
DRUG

Ozanimod

Women with UC exposed to ozanimod during pregnancy

DRUG

Conventional therapy

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

DRUG

Advanced therapy

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

Trial Locations (1)

55344

OptumInsight Life Sciences Inc, Eden Prairie

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY