A Study to Evaluate the Safety of Ozanimod Exposure Durin... | NCT06133049

Studies
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants

NCT06133049

Sponsor

Bristol-Myers Squibb

Status

Active, not recruiting

Last Update Posted

Nov 15, 2023Actual

Enrollment

2,961Estimated

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Ozanimod
Select DMTs other than ozanimod
No DMTs

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2021Actual

Primary Completion Date

Mar 31, 2031Estimated

Completion Date

Aug 31, 2031Estimated

First Submitted Date

Oct 18, 2023

First Submission Date that Met QC Criteria

Nov 9, 2023

First Posted Date

Nov 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2023

Last Update Posted Date

Nov 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,961Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ozanimod exposed			Drug: Ozanimod
Other DMT exposed			Drug: Select DMTs other than ozanimod
Not DMT exposed			Drug: No DMTs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozanimod	Drug	Women with MS who were exposed to ozanimod during pregnancy	Ozanimod exposed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	Up to 11 years

Secondary Outcomes

Measure	Description	Time Frame
Number of spontaneous abortions		Up to 11 years
Number of preterm births		Up to 11 years
Number of stillbirths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 18 to 49 years at date of conception
Date of conception between April 1, 2020 and July 31, 2030

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Pregnant adult women with MS with an estimated date of conception between April 1, 2020 and July 31, 2030

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OptumInsight Life Sciences Inc		Eden Prairie	Minnesota	55344	United States

Label	URL
BMS Clinical Trial Information	View source

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000607776	ozanimod

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided