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

Biogen

Status: Completed

Conditions: Multiple Sclerosis; Pregnancy; Prenatal Exposure Delayed Effects

Treatments: Drug: BG9418 (interferon beta-1a)

Study type: Observational

Funder types: Industry

Identifiers

NCT00168714

C-871

Details and patient eligibility

About

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.

Enrollment: 329 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

329 participants in 1 patient group

Pregnant participants

Description:

Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy

Treatment:

Drug: BG9418 (interferon beta-1a)