Pregnancy Exposure Registry for Tysabri
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||TYSABRI Pregnancy Exposure Registry|
- Pregnancy Outcomes: Spontaneous Abortions, Birth Defects [ Time Frame: same day outcome is known ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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.
|Contact: Biogen Idecfirstname.lastname@example.org|
|United States, West Virginia|
|United BioSource Corporation||Recruiting|
|Morgantown, West Virginia, United States, 26505|
|Contact 866-831-2358 LSKC.BiogenIdec.Tysabri@unitedbiosource.com|