Multiple SclerosisNCT06133049
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
An observational study of Multiple Sclerosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ozanimod, Select DMTs other than ozanimod and No DMTs
- How many people
- 2,961 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 31 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant adult women with MS with an estimated date of conception between April 1, 2020 and July 31, 2030
Who may be able to join
- Women aged 18 to 49 years at date of conception
- Date of conception between April 1, 2020 and July 31, 2030
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OptumInsight Life Sciences Inc
Eden Prairie, Minnesota, 55344
About this study
Official title: Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Ozanimod, Select DMTs other than ozanimod, No DMTs
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzanimodDrug
Women with MS who were exposed to ozanimod during pregnancy
Select DMTs other than ozanimodDrug
Women with MS exposed to select DMTs other than ozanimod during pregnancy
No DMTsDrug
Women with MS not exposed to any DMTs during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod exposed | Not described Receives: Drug: Ozanimod | |
| Other DMT exposed | Not described Receives: Drug: Select DMTs other than ozanimod | |
| Not DMT exposed | Not described Receives: Drug: No DMTs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of major congenital malformations among infants
Prevalence of major congenital malformations among infants born to women with MS exposed to ozanimod during the first trimester, and to compare this to the prevalence among each of the two comparator groups of pregnant women (other DMT exposed or NO DMT exposed)
Measured: Up to 11 years
Secondary outcomes (13)
Number of spontaneous abortions
Measured: Up to 11 years
Number of preterm births
Measured: Up to 11 years
Number of stillbirths
Measured: Up to 11 years
Number of participants with pre-eclampsia
Measured: Up to 11 years
Number of participants with eclampsia
Measured: Up to 11 years
Number of infants small for gestational age
Measured: Up to 11 years
Number of serious or opportunistic infections in liveborn infants up to one year of age
Measured: Up to 11 years
Number of infant postnatal growth deficiencies
Measured: Up to 11 years
Number of infant developmental deficiencies
Measured: Up to 11 years
Number of neonatal hospitalizations
Measured: Up to 11 years
Number of infant deaths
Measured: Up to 11 years
Number of neonatal deaths
Measured: Up to 11 years
Number of perinatal deaths
Measured: Up to 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start16 Mar 2021
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,961 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133049
- Sponsor's protocol ID
- IM047-002
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zeposia (Ozanimod) Pregnancy Study: A Retrospective Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
- ClinicalTrials.gov ID
- NCT06133049
- Acronym / sponsor ID
- IM047-002
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,961 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozanimod exposed | – | Drug: Ozanimod |
| Other DMT exposed | – | Drug: Select DMTs other than ozanimod |
| Not DMT exposed | – | Drug: No DMTs |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant adult women with MS with an estimated date of conception between April 1, 2020 and July 31, 2030
Key inclusion criteria (2 listed)
- Women aged 18 to 49 years at date of conception
- Date of conception between April 1, 2020 and July 31, 2030
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzanimodWomen with MS who were exposed to ozanimod during pregnancy | Drug | Ozanimod exposed |
| Select DMTs other than ozanimodWomen with MS exposed to select DMTs other than ozanimod during pregnancy | Drug | Other DMT exposed |
| No DMTsWomen with MS not exposed to any DMTs during pregnancy | Drug | Not DMT exposed |
Primary outcome
Prevalence of major congenital malformations among infants
Time frame: Up to 11 years
Prevalence of major congenital malformations among infants born to women with MS exposed to ozanimod during the first trimester, and to compare this to the prevalence among each of the two comparator groups of pregnant women (other DMT exposed or NO DMT exposed)
13 secondary outcomes
Number of spontaneous abortions
Time frame: Up to 11 years
Number of preterm births
Time frame: Up to 11 years
Number of stillbirths
Time frame: Up to 11 years
Number of participants with pre-eclampsia
Time frame: Up to 11 years
Number of participants with eclampsia
Time frame: Up to 11 years
Number of infants small for gestational age
Time frame: Up to 11 years
Number of serious or opportunistic infections in liveborn infants up to one year of age
Time frame: Up to 11 years
Number of infant postnatal growth deficiencies
Time frame: Up to 11 years
Number of infant developmental deficiencies
Time frame: Up to 11 years
Number of neonatal hospitalizations
Time frame: Up to 11 years
Number of infant deaths
Time frame: Up to 11 years
Number of neonatal deaths
Time frame: Up to 11 years
Number of perinatal deaths
Time frame: Up to 11 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of major congenital malformations among infants (time frame: Up to 11 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.