An observational study in Ulcerative Colitis, sponsored by Bristol-Myers Squibb. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Bristol-Myers Squibb · Observational
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.
1,073 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's planned enrollment of 2,828 is above the median of 105 across 248 observational studies indexed under Colitis.
Browse Colitis studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult women with UC who became pregnant between June 1, 2021 and September 1, 2030
Exclusion Criteria:
Drug: Ozanimod
Drug: Conventional therapy
Drug: Advanced therapy
Women with UC exposed to ozanimod during pregnancy
Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy
Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy
Prevalence of major congenital malformations among infants
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.
Time frame: Up to 10 years
Number of spontaneous abortions
Time frame: Up to 10 years
Number of stillbirths
Time frame: Up to 10 years
Number of participants with pre-eclampsia
Time frame: Up to 10 years
Number of participants with eclampsia
Time frame: Up to 10 years
Number of preterm births
Time frame: Up to 10 years
Number of infants small for gestational age
Time frame: Up to 10 years
Number of serious or opportunistic infections in liveborn infants up to 1 year of age
Time frame: Up to 10 years
Number of infant postnatal growth deficiencies
Time frame: Up to 10 years
Number of infant developmental deficiencies
Time frame: Up to 10 years
Number of neonatal hospitalizations
Time frame: Up to 10 years
Number of infant deaths
Time frame: Up to 10 years
Number of neonatal deaths
Time frame: Up to 10 years
Number of perinatal deaths
Time frame: Up to 10 years
Plan to share: No
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb