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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00168714
Other study ID # C-871
Secondary ID
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


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
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