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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant participants | Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG9418 (interferon beta-1a) | Drug | Exposure to Avonex during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Key Inclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
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Pregnant women with MS who were exposed to Avonex in the US
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendle | Wilmington | North Carolina | 28405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37737962 | Derived | Weinstock-Guttman B, Ross AP, Planton J, White K, Pandhi A, Greco A, Kumar A, Everage N, Vignos M. Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX(R) Pregnancy Exposure Registry. Drugs Real World Outcomes. 2023 Dec;10(4):503-511. doi: 10.1007/s40801-023-00384-0. Epub 2023 Sep 22. |
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| ID | Term |
|---|---|
| D011297 | Prenatal Exposure Delayed Effects |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D049188 | Prenatal Injuries |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |