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

Multiple Sclerosis Clinical Trial

Official title:

Avonex Pregnancy Exposure Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168714
• Other study ID #: C-871
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: June 6, 2014
• Start date: February 2004
• Est. completion date: September 2011

Study information

• Verified date: June 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pregnancy
• Prenatal Exposure Delayed Effects

Intervention

Drug:
• BG9418 (interferon beta-1a)
Exposure to Avonex during pregnancy

Locations

Country	Name	City	State
United States	Kendle	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes

External Links

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