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

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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Key information

Conditions

Prenatal Exposure Delayed Effects Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Multiple Sclerosis Nervous System Diseases Pregnancy Pregnancy Complications Prenatal Injuries Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Kendle

Wilmington, North Carolina, 28405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG9418 (Interferon beta-1a)

Drug

Exposure to Avonex during pregnancy

Other names: Avonex

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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Avonex Pregnancy Exposure Registry

Important dates

Study start: 2004
Primary completion: 2011
Study completion: 2011
First posted: Sep 15, 2005
Registry last updated: Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed