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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00168714
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Biogen Idec
• Public title: Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
• Scientific title: Avonex Pregnancy Exposure Registry
• Date of first enrolment: February 2004
• Target sample size: 329
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00168714
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen Idec

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Prenatal Exposure Delayed Effects

Multiple Sclerosis

Pregnancy

Intervention(s)

Drug: BG9418 (interferon beta-1a)

Primary Outcome(s)

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]

Secondary ID(s)

C-871

Source(s) of Monetary Support

Please refer to primary and secondary sponsors