Biogen Multiple Sclerosis Pregnancy Exposure Registry

Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Exposure During Pregnancy
• Intervention / Treatment: Drug: Dimethyl fumarate; Drug: Peginterferon beta-1a

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 408

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Research Site
• Canada
  • Massachusetts
    • Cambridge, Massachusetts, Canada, 02139-1955
      • Research Site
• France
  • Cedex
    • Bron CEDEX, Cedex, France, 69677
      • Research Site
• Germany
  • Nordrhein Wesfalen
    • Bochum, Nordrhein Wesfalen, Germany, 44791
      • Research Site
• Ireland
  • Dublin, Ireland, D04 T6F4
    • Research Site
• Italy
  • Firenze, Italy, 50134
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Palermo, Italy, 90146
    • Research Site
  • Roma, Italy, 00152
    • Research Site
• Poland
  • Białystok, Poland, 15-276
    • Research Site
• Spain
  • Madrid, Spain, 28034
    • Research Site
  • Malaga, Spain, 29010
    • Research Site
• United Kingdom
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Research Site
• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139-1955
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Within each product cohort, approximately 310 to 375 pregnant women exposed to a Registry-specified Biogen MS product will be enrolled in order to observe 300 prospective pregnancy outcomes. The infants born to these women will also be part of the population studied. Patients with prenatal testing prior to enrollment (with the exception of a first trimester ultrasound to date the pregnancy) will not be counted towards the 300 prospective pregnancy outcomes.

Description

Key Inclusion Criteria:

• 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.

Key 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dimethyl fumarate; Exposure to dimethyl fumarate since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy	Drug: Dimethyl fumarate; Administered as specified in treatment arm.; Other Names: BG00012; DMF; Tecfidera
Peginterferon beta-1a; Exposure to Peginterferon beta-1a since 17 days prior to the first day of her LMP prior to conception or at any time during pregnancy.	Drug: Peginterferon beta-1a; Administered as specified in treatment arm.; Other Names: Plegridy; BIIB017
Disease Modifying Therapy (DMT) Unexposed; Never received DMT therapy; discontinued treatment with any DMT at least more than 5× half-life prior to Day 1 of her LMP and throughout the entire pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Loss	Elective or therapeutic pregnancy terminations (any induced or voluntary fetal loss during pregnancy); Spontaneous abortions (<22 weeks of gestation); Fetal death, including stillbirths (fetuses born dead at >=22 weeks of gestation), which will be further classified as follows:; early fetal loss (fetal death occurring at >=22 weeks but <28 weeks of gestation); late fetal loss (occurring at >=28 weeks of gestation)	During pregnancy up to 52 weeks post-delivery
Live Birth	Premature birth (delivered <37 weeks); Full-term birth (delivered >=37 weeks)	During pregnancy up to 52 Weeks Post-Delivery

Collaborators and Investigators

• Sponsor: Biogen

Publications and helpful links

General Publications

• Hellwig K, Rog D, McGuigan C, Houtchens MK, Bruen DR, Mokliatchouk O, Branco F, Peng X, Everage NJ. Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 23;9(1):e1114. doi: 10.1212/NXI.0000000000001114. Print 2022 Jan.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2013
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: 109MS402