Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

NCT05658497 | Recruiting FDA Drug

• 1 other identifier: 272MS401
• Study Type: observational
• Target: 908
• Locations: 6 countries
• Sites: 7

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Pregnancy; Relapsing forms of MS

Outcome Measures

Primary Outcomes (1)

• Number of Major Congenital Malformations (MCMs)

  MCMs include abnormalities in structural development that are medically or cosmetically significant are present at birth, and persist in postnatal life unless or until repaired as evaluated by independent advisors used throughout the registry.

  Up to 52 weeks postdelivery

Secondary Outcomes (13)

• Number of Elective or Therapeutic Terminations

  Up to 9 months of pregnancy

• Number of Spontaneous Abortions

  Before 22 weeks of gestation

• Number of Fetal Deaths Including Still Birth

  At or after 22 weeks of gestation

• Number of Live Births

  Up to delivery (approximately 10 months)

• Number of Ectopic Pregnancies

  Up to 9 months of pregnancy

Study Arms (5)

Diroximel Fumarate

Pregnant women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.

Drug: Diroximel Fumarate

Disease Modifying Therapy (DMTs) Exposed

Pregnant women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries) at any time from 2 weeks after the first day of their LMP through the end of pregnancy.

Drug: Avonex; Biological: Tysabri

DMTs Unexposed

Pregnant women who were unexposed to DMT which is defined as either never received a DMT or discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP 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.

Dimethyl Fumarate

Pregnant women with MS who were exposed to DMF at any time from 2 weeks after the first day of their LMP through the end of pregnancy.

Drug: Dimethyl Fumarate

Women Without MS

Pregnant women with external, general population comparators.

Interventions

Diroximel Fumarate DRUG

Administered as specified in the treatment arm.

Also known as: VUMERITY, BIIB098

Diroximel Fumarate

Avonex DRUG

Administered as specified in the treatment arm.

Also known as: BG9418, interferon beta-1a

Disease Modifying Therapy (DMTs) Exposed

Tysabri BIOLOGICAL

Administered as specified in the treatment arm.

Also known as: Natalizumab, BG00002

Disease Modifying Therapy (DMTs) Exposed

Dimethyl Fumarate DRUG

Administered as specified in the treatment arm.

Also known as: Tecfidera, DMF, BG00012

Dimethyl Fumarate

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant female participants with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP up through any time during pregnancy and compared with pregnancies among women with MS who were exposed to DMF, women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), women with MS who were unexposed to DMTs, and women without MS. Participants will be classified into 2 enrolment types, Prospective and Retrospective. Prospective registration:a report of a pregnancy enrolled prior to knowledge of the pregnancy outcome, including prior to the detection of a congenital malformation at prenatal testing. Women who enrol after any knowledge of the pregnancy outcome will be enrolled as retrospective cases but will not be included in the primary analysis, i.e.,pregnancies with a prenatal testing result indicative of any congenital malformation/pregnancies with known outcomes at time of initial report.

You may qualify if:

• 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)

You may not qualify if:

• \- None

Sponsors & Collaborators

• Biogen: lead

Study Sites (7)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

IQVIA US Office

Durham, North Carolina, 27703, United States

RECRUITING

Austin Hospital

Heidelberg, 3084, Australia

RECRUITING

Katholisches Klinikum Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

St Vincent's University Hospital

Dublin, DO4 T6F4, Ireland

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

diroximel fumarate; Interferon beta-1a; Natalizumab; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Central Study Contacts

US Biogen Clinical Trial Center

CONTACT

866-633-4636; clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

CONTACT

clinicaltrials@biogen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: October 27, 2023
• Primary Completion (Estimated): July 6, 2032
• Study Completion (Estimated): July 6, 2032
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2); ES (1); CH (1); DE (1); AU (1); IE (1)