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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prenatal Exposure Delayed Effects; Multiple Sclerosis; Pregnancy

Intervention: BG9418 (interferon beta-1a) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

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.

Clinical Details

Official title: Avonex Pregnancy Exposure Registry

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Record and analyze birth defects and spontaneous fetal losses

Record and analyze pregnancy outcomes

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Kendle, Wilmington, North Carolina 28405, United States
Additional Information

Starting date: February 2004
Last updated: June 6, 2014

Page last updated: August 20, 2015

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