Biogen Multiple Sclerosis Pregnancy Exposure Registry

June 17, 2022 updated by: Biogen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pregnancy Loss
Time Frame: During pregnancy up to 52 weeks post-delivery
  • 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
Time Frame: During pregnancy up to 52 Weeks Post-Delivery
  • Premature birth (delivered <37 weeks)
  • Full-term birth (delivered >=37 weeks)
During pregnancy up to 52 Weeks Post-Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 109MS402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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