Multiple Sclerosis Clinical Trial

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Summary

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP.
Presence of MS.

Key Exclusion Criteria:

- Pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

1178

Study ID:

NCT05688436

Recruitment Status:

Recruiting

Sponsor:

Biogen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

OptumInsight
Eden Prairie Minnesota, 55344, United States More Info
Optum Research Database
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

1178

Study ID:

NCT05688436

Recruitment Status:

Recruiting

Sponsor:


Biogen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider