Multiple Sclerosis Clinical Trial

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Summary

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).

The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Participant must have a diagnosis of MS

Documentation that the participant was one of the following:

exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)
Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)

Key Exclusion Criteria:

- None

NOTE: Other protocol defined Inclusion criteria may apply

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

908

Study ID:

NCT05658497

Recruitment Status:

Recruiting

Sponsor:

Biogen

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There are 4 Locations for this study

See Locations Near You

IQVIA US Office
Durham North Carolina, 27703, United States More Info
Contact
833-569-2635
Sydney Willis
Principal Investigator
Katholisches Klinikum Bochum
Bochum Nordrhein Westfalen, 44791, Germany More Info
Contact
+492345092420
Kerstin Hellwig
Principal Investigator
St Vincent's University Hospital
Dublin , DO4 T, Ireland More Info
Contact
+35312773592
Christopher McGuigan
Principal Investigator
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Contact
+34913368397
Lucienne Costa-Frossard
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

908

Study ID:

NCT05658497

Recruitment Status:

Recruiting

Sponsor:


Biogen

How clear is this clinincal trial information?

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