Biogen Multiple Sclerosis Pregnancy Exposure Registry
Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry
1 other identifier
observational
408
10 countries
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2013
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedStudy Start
First participant enrolled
October 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedJune 21, 2022
June 1, 2022
8.3 years
July 25, 2013
June 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
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
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.
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.
Interventions
Administered as specified in treatment arm.
Administered as specified in treatment arm.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (15)
Research Site
Cambridge, Massachusetts, 02139-1955, United States
Research Site
Box Hill, Victoria, 3128, Australia
Research Site
Cambridge, Massachusetts, 02139-1955, Canada
Research Site
Bron, Cedex, 69677, France
Research Site
Bochum, Nordrhein Wesfalen, 44791, Germany
Research Site
Dublin, D04 T6F4, Ireland
Research Site
Florence, 50134, Italy
Research Site
Genova, 16132, Italy
Research Site
Milan, 20132, Italy
Research Site
Palermo, 90146, Italy
Research Site
Roma, 00152, Italy
Research Site
Bialystok, 15-276, Poland
Research Site
Madrid, 28034, Spain
Research Site
Málaga, 29010, Spain
Research Site
Salford, Greater Manchester, M6 8HD, United Kingdom
Related Publications (1)
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.
PMID: 34815321DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 52 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2013
First Posted
July 30, 2013
Study Start
October 30, 2013
Primary Completion
February 10, 2022
Study Completion
February 10, 2022
Last Updated
June 21, 2022
Record last verified: 2022-06