Biogen Multiple Sclerosis Pregnancy Exposure Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01911767
First received: July 25, 2013
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

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 dimtheyl fumarate and Pegylated human interferon beta-1a.


Condition Intervention
Multiple Sclerosis
Exposure During Pregnancy
Drug: dimethyl fumarate
Drug: Peginterferon beta-1a

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 52 Weeks
Official Title: Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Negative birth outcomes, including spontaneous abortions and birth defects. [ Time Frame: During pregnancy up to 52 weeks post-delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: June 2013
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Provided under routine clinical care
Other Names:
  • Tecfidera
  • BG00012
  • DMF
Peginterferon beta-1a
Exposure to Peginterferon beta-1a since 14 days prior to the first day of her LMP prior to conception or at any time during pregnancy.
Drug: Peginterferon beta-1a
Provided under routine clinical care
Other Names:
  • Plegridy
  • BIIB017

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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 14 days prior to the first day of her LMP prior to conception or at any time during pregnancy.

Key Exclusion Criteria:

  • Prenatal testing that could provide knowledge of the outcome of pregnancy must not have been performed prior to the time of enrollment (e.g., alpha fetoprotein, sonography, amniocentesis). However, 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., syphilis) in the opinion of the health care professional.
  • The outcome of the pregnancy must not be known at the time of enrollment.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911767

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
United States, Florida
Research Site Not yet recruiting
Maitland, Florida, United States, 32751
United States, Virginia
Research Site Recruiting
Reston, Virginia, United States, 20191
Australia, Victoria
Research Site Recruiting
Box Hill, Victoria, Australia
Germany
Research Site Recruiting
Bochum, Germany, 44791
Ireland
Research Site Not yet recruiting
Dublin, Ireland, 4
Italy
Research Site Not yet recruiting
Firenze, Italy
Spain
Research Site Not yet recruiting
Malaga, Spain, S/N 29010
United Kingdom
Research Site Recruiting
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01911767     History of Changes
Other Study ID Numbers: 109MS402
Study First Received: July 25, 2013
Last Updated: July 23, 2015
Health Authority: Ireland: Irish Medicines Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Dimethyl fumarate
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015