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| ID | Type | Description | Link |
|---|---|---|---|
| NEONATAL MONITORING |
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This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with potential exposure in utero |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unintentional exposure in utero | Other | This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study). |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley Infant Neurodevelopmental Screener | 0-2 Months | |
| Bayley Infant Neurodevelopmental Screener | 8 months | |
| Bayley Infant Neurodevelopmental Screener | 15 months | |
| Receptive-Expressive Emergent Language Test | 0-2 Months | |
| Receptive-Expressive Emergent Language Test | 8 months | |
| Receptive-Expressive Emergent Language Test | 15 months |
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Inclusion Criteria:
Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.
Exclusion Criteria:
There are no exclusion criteria for this study
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Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Tempe | Arizona | 85282 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Tempe |
| Arizona |
| 85283 |
| United States |
| Pfizer Investigational Site | Wildomar | California | 92595 | United States |
| Pfizer Investigational Site | Cutler Bay | Florida | 33189 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119-5214 | United States |
| Pfizer Investigational Site | Houston | Texas | 77065 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84109 | United States |