Avonex Pregnancy Exposure Registry
Overview
- Phase
- Not Applicable
- Intervention
- BG9418 (interferon beta-1a)
- Conditions
- Prenatal Exposure Delayed Effects
- Sponsor
- Biogen
- Enrollment
- 329
- Locations
- 1
- Primary Endpoint
- Record and analyze birth defects and spontaneous fetal losses
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Pregnant participants
Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy
Intervention: BG9418 (interferon beta-1a)
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