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

Completed

• Conditions: Prenatal Exposure Delayed Effects; Multiple Sclerosis; Pregnancy
• Interventions: Drug: BG9418 (interferon beta-1a)

• Registration Number: NCT00168714
• Lead Sponsor: Biogen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 329

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant participants	BG9418 (interferon beta-1a)	Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy

Primary Outcome Measures

Name	Time	Method
Record and analyze birth defects and spontaneous fetal losses	Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Record and analyze pregnancy outcomes	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

Trial Locations

Locations (1)

Kendle; 🇺🇸 Wilmington, North Carolina, United States