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

Biogen329 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

329

Conditions

Prenatal Exposure Delayed Effects Multiple Sclerosis Pregnancy

Interventions

BG9418 (interferon beta-1a)DRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Key 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). NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Record and analyze birth defects and spontaneous fetal losses

Time frame: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy

Record and analyze pregnancy outcomes

Time frame: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.