Status:
COMPLETED
Biogen Multiple Sclerosis Pregnancy Exposure Registry
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Exposure During Pregnancy
Eligibility:
FEMALE
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 th...
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 R...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 30 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT01911767
Start Date
October 30 2013
End Date
February 10 2022
Last Update
June 21 2022
Active Locations (15)
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1
Research Site
Cambridge, Massachusetts, United States, 02139-1955
2
Research Site
Box Hill, Victoria, Australia, 3128
3
Research Site
Cambridge, Massachusetts, Canada, 02139-1955
4
Research Site
Bron, Cedex, France, 69677