Biogen Multiple Sclerosis Pregnancy Exposure Registry

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    1125
  • sponsor
    Biogen
Updated on 5 May 2021
interferon
disease or disorder
dimethyl fumarate

Summary

The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).

Description

The Biogen Multiple Sclerosis Pregnancy Exposure Registry is a prospective, observational registry designed to evaluate pregnancy outcomes in women with multiple sclerosis (MS) who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. Women of childbearing potential are a considerable segment of the patient population affected by MS and are likely to be exposed to a Registry-specified Biogen MS product around the time of conception and during pregnancy. Biogen completed pregnancy registries for Avonex and Tysabri; however, formal studies in pregnant women have not been conducted. Therefore, it is important to evaluate, in a global Pregnancy Registry, how exposure to a marketed Biogen MS product specified in this Pregnancy Registry may affect pregnancy and infant outcomes. Data will be collected on prospective pregnancies (i.e. enrollment prior to knowledge of outcome) at time of enrollment, 6 to 7 months gestation, and approximately 4,12, and 52 weeks after estimated date of delivery. The prevalence of spontaneous abortions, birth defects, and other pregnancy and infant outcomes will be calculated and compared to background rates from external sources such as the European Surveillance of Congenital Anomalies.

Details
Condition Multiple Sclerosis, Exposure During Pregnancy, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms), pregnancy exposure
Treatment dimethyl fumarate, Peginterferon beta-1a, Dalclizumab High Yield Process
Clinical Study IdentifierNCT01911767
SponsorBiogen
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Are you female?
Do you have any of these conditions: Exposure During Pregnancy or Multiple Sclerosis or Radiologically Isolated Syndrome or Dermatite Atopique modérée ou grave?
Do you have any of these conditions: Exposure During Pregnancy or Dermatite Atopique modérée ou grave or Multiple Sclerosis or Radiologically Isolated Syndrome or pregnancy exposure or mu...?
Do you have any of these conditions: Radiologically Isolated Syndrome or Exposure During Pregnancy or pregnancy exposure or multiple sclerosis (ms) or Dermatite Atopique modérée ou grave ...?
Do you have any of these conditions: multiple sclerosis (ms) or Exposure During Pregnancy or Dermatite Atopique modérée ou grave or pregnancy exposure or Multiple Sclerosis or Radiologica...?
Do you have any of these conditions: pregnancy exposure or Radiologically Isolated Syndrome or Exposure During Pregnancy or multiple sclerosis (ms) or Multiple Sclerosis or Dermatite Atop...?
Do you have any of these conditions: pregnancy exposure or Radiologically Isolated Syndrome or Exposure During Pregnancy or multiple sclerosis (ms) or Multiple Sclerosis or Dermatite Atop...?
Patient consent
Patient has a diagnosis of MS
Documentation that the patient was exposed to a Registry-specified Biogen MS product during the eligibility window for that product
DMF: Exposure since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy
Peginterferon beta-1a: Exposure since 17 days prior to the first day of her LMP prior to conception or at any time during pregnancy
DMT unexposed pregnancy cohort: Never received DMT therapy
Patient agrees to sign the Release of Medical Information Form, thereby permitting the Registry to contact her health care provider (HCP(s)) and the pediatric HCP for medical information

Exclusion Criteria

The outcome of the pregnancy (i.e., pregnancy loss or live birth) must not be known at the time of enrollment
Initial maternal health assessment upon confirmation of pregnancy does not preclude participation in the Registry unless a patient tests positive for a medical condition associated with negative pregnancy outcomes (e.g., toxoplasmosis screen and syphilis [venereal disease research laboratory test and rapid plasma reagin test] blood screen) in the opinion of the healthcare provider (HCP)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply
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