Biogen Multiple Sclerosis Pregnancy Exposure Registry

NCT ID: NCT01911767

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 408 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-30
• Study Completion Date: 2022-02-10

Brief 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).

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.

Conditions

Multiple Sclerosis; Exposure During Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Dimethyl fumarate

Intervention Type: DRUG

Administered as specified in treatment arm.

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.

Peginterferon beta-1a

Intervention Type: DRUG

Administered as specified in treatment arm.

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.

No interventions assigned to this group

Interventions

Dimethyl fumarate

Administered as specified in treatment arm.

Intervention Type: DRUG

Peginterferon beta-1a

Administered as specified in treatment arm.

Intervention Type: DRUG

Other Intervention Names

Tecfidera; BG00012; DMF; Plegridy; BIIB017

Eligibility Criteria

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.

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).

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Cambridge, Massachusetts, United States

Research Site

Box Hill, Victoria, Australia

Research Site

Cambridge, Massachusetts, Canada

Research Site

Bron, Cedex, France

Research Site

Bochum, Nordrhein Wesfalen, Germany

Research Site

Dublin, , Ireland

Research Site

Florence, , Italy

Research Site

Genova, , Italy

Research Site

Milan, , Italy

Research Site

Palermo, , Italy

Research Site

Roma, , Italy

Research Site

Bialystok, , Poland

Research Site

Madrid, , Spain

Research Site

Málaga, , Spain

Research Site

Salford, Greater Manchester, United Kingdom

Countries

United States; Australia; Canada; France; Germany; Ireland; Italy; Poland; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34815321 (View on PubMed)

Other Identifiers

109MS402

Identifier Type: -

Identifier Source: org_study_id