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

Sponsor
Biogen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05688436
Collaborator
(none)
825
1
111.8
7.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Diroximel Fumarate
  • Biological: Alemtuzumab
  • Drug: Fingolimod
  • Drug: Glatiramer acetate
  • Biological: Interferon beta
  • Biological: Natalizumab
  • Biological: Ocrelizumab
  • Biological: Peginterferon beta-1a
  • Drug: Siponimod

Study Design

Study Type:
Observational
Anticipated Enrollment :
825 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
Actual Study Start Date :
Sep 24, 2021
Anticipated Primary Completion Date :
Jan 17, 2031
Anticipated Study Completion Date :
Jan 17, 2031

Arms and Interventions

Arm Intervention/Treatment
Diroximel Fumarate (DRF)

Pregnant women with MS who were exposed to DRF 12 months prior to last menstrual period (LMP).

Drug: Diroximel Fumarate
Administered as specified in the treatment arm.
Other Names:
  • VUMERITY
  • BIIB098
  • Non-DRF

    Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF 12 months prior to LMP.

    Biological: Alemtuzumab
    Administered as specified in the treatment arm.

    Drug: Fingolimod
    Administered as specified in the treatment arm.

    Drug: Glatiramer acetate
    Administered as specified in the treatment arm.

    Biological: Interferon beta
    Administered as specified in the treatment arm.

    Biological: Natalizumab
    Administered as specified in the treatment arm.
    Other Names:
  • Tysabri
  • BG00002
  • Biological: Ocrelizumab
    Administered as specified in the treatment arm.

    Biological: Peginterferon beta-1a
    Administered as specified in the treatment arm.

    Drug: Siponimod
    Administered as specified in the treatment arm.

    Non-DMT

    Pregnant women with MS who were not exposed to DMTs.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Major Congenital Malformations (MCMs) [Up to 52 weeks postdelivery]

      MCMs includes abnormalities in structural development that are medically or cosmetically significant are present at birth and persist in postnatal life unless or until repaired.

    Secondary Outcome Measures

    1. Number of Spontaneous Abortions [Before 20 weeks of gestation]

      Spontaneous abortion is defined as the loss of a fetus due to natural causes before 20th week of gestation.

    2. Number of Preterm Births [At or before the 37 weeks of gestation]

      Preterm birth is defined as a live birth at or before the 37th week of gestation.

    3. Number of Stillbirths [At or after the 20 weeks of gestation]

      Stillbirth is defined as the loss of pregnancy at or after the 20th week of gestation.

    4. Number of Small for Gestational Age (SGA) [Up to 52 weeks postdelivery]

      SGA is defined as birthweight below the 10th percentile for gestational age.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OptumInsight Eden Prairie Minnesota United States 55344-2503

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT05688436
    Other Study ID Numbers:
    • 272MS402
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biogen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2023