Status:
COMPLETED
Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
Lead Sponsor:
Biogen
Conditions:
Prenatal Exposure Delayed Effects
Multiple Sclerosis
Eligibility:
FEMALE
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 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT00168714
Start Date
February 1 2004
End Date
September 1 2011
Last Update
June 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kendle
Wilmington, North Carolina, United States, 28405