NCT06133049Active, not recruiting
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Source: ClinicalTrials.gov · Last updated 15 Nov 2023
Brief summary (registry, in English)
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2961 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 16 Mar 2021
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple sclerosis
- NCT number
- NCT06133049
What you commit to
- Study type: Observational
- Planned participants: 2961
- From 16 Mar 2021 to the primary completion date, 31 Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Exposure to the DMTs fingolimod, siponimod, mitoxantrone, and teriflunomide within a period of 5 half-lives prior to the estimated date of conception through the end of the first trimester
Who the study is looking for
- Women aged 18 to 49 years at date of conception
- Date of conception between April 1, 2020 and July 31, 2030
Age in the registry: 18 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OptumInsight Life Sciences Inc Coordinator of this site? Confirm its status | Eden Prairie | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.