Biogen Multiple Sclerosis Pregnancy Exposure Registry

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Biogen

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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.

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Treatment Details

Interventions

Dimethyl fumarate (Immunomodulator)
Peginterferon beta-1a (Interferon)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Peginterferon beta-1aExperimental Treatment1 Intervention

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.

Group II: Disease Modifying Therapy (DMT) UnexposedExperimental Treatment0 Interventions

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.

Group III: Dimethyl fumarateExperimental Treatment1 Intervention

Exposure to dimethyl fumarate since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy