Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2011-09-30

Brief Summary

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The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.

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Detailed Description

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Conditions

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Prenatal Exposure Delayed Effects Multiple Sclerosis Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant participants

Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy

BG9418 (interferon beta-1a)

Intervention Type DRUG

Exposure to Avonex during pregnancy

Interventions

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BG9418 (interferon beta-1a)

Exposure to Avonex during pregnancy

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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Inclusion Criteria

* Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy.
* Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively).
* Provide verbal consent to participate in the Registry.
* Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No