Pregnancy Exposure Registry for Tysabri
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Women's Studies, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/5/2014 |
| Start Date: | January 2007 |
| End Date: | June 2016 |
| Contact: | Biogen Idec |
| Email: | neurologyclinicaltrials@biogenidec.com |
TYSABRI Pregnancy Exposure Registry
The purpose of this Registry is to monitor pregnant subjects and fetuses inadvertently
exposed to TYSABRI® and to detect any potential increase in the risk of both major birth
defects and spontaneous pregnancy loss.
exposed to TYSABRI® and to detect any potential increase in the risk of both major birth
defects and spontaneous pregnancy loss.
This study will be conducted in coordination with the TYSABRI® Global Observational Program
in Safety (TYGRIS) observational study in the United States (US), Canada, and Rest of World
(ROW).
The Coordinating Center (CC) will monitor patients throughout their pregnancies and will
monitor the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks
after the Estimated Date of Delivery (EDD) in the ROW.
in Safety (TYGRIS) observational study in the United States (US), Canada, and Rest of World
(ROW).
The Coordinating Center (CC) will monitor patients throughout their pregnancies and will
monitor the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks
after the Estimated Date of Delivery (EDD) in the ROW.
Females who become pregnant while they are taking TYSABRI® as part of the TYGRIS program,
during a clinical trial with TYSABRI® that is sponsored by Biogen-Idec, or in the
post-marketing setting may enroll in this Registry. Patients must be exposed to TYSABRI®
within 3 months prior to conception or during pregnancy to be eligible. The outcome of the
pregnancy must not be known at the time of enrollment.
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