Biogen Multiple Sclerosis Pregnancy Exposure Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01911767
First received: July 25, 2013
Last updated: August 3, 2016
Last verified: August 2016
  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 dimethyl fumarate, Pegylated human interferon beta-1a, and Dalclizumab High Yield Process (DAC HYP).

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

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: October 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
Dalclizumab High Yield Process
Exposure to Dalclizumab High Yield Process 90 days prior to the first day of her LMP prior to conception or at any time during pregnancy.
Drug: Dalclizumab High Yield Process
Provided under routine clinical care
Other Name: DAC HYP, Zinbryta

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
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. 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.
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.
  • DAC HYP: Exposure since 90 days prior to the first day of her LMP prior to conception or at any time during pregnancy
  • 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.

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, Massachusetts
Research Site Recruiting
Cambridge, Massachusetts, United States, 02139-1955
Australia, Victoria
Research Site Recruiting
Box Hill, Victoria, Australia, 3128
Germany
Research Site Recruiting
Bochum, Nordrhein Wesfalen, Germany, 44791
Ireland
Research Site Recruiting
Dublin 4, Dublin, Ireland, DU 4
Italy
Research Site Recruiting
Firenze, Italy, 50134
Research Site Recruiting
Genova, Italy, 16132
Research Site Recruiting
Milano, Italy, 20132
Research Site Recruiting
Palermo, Italy, 90146
Research Site Recruiting
Roma, Italy, 00152
Spain
Research Site Recruiting
Malaga, Spain, 29010
United Kingdom
Research Site Recruiting
Salford, Greater Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01911767     History of Changes
Other Study ID Numbers: 109MS402 
Study First Received: July 25, 2013
Last Updated: August 3, 2016
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:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Interferon-beta
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 30, 2016