NCT00472992

Pregnancy Exposure Registry for Tysabri®

TYSABRI® Pregnancy Exposure Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 376 (actual)
• Sponsor: Biogen · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.

Detailed description

This study was 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) monitored participants throughout their pregnancies and monitored 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.

Conditions

• Crohn's Disease
• Prenatal Exposure
• Multiple Sclerosis
• Pregnancy

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2007-05-14
• Last updated: 2014-08-11

Locations

1 site across 1 country: United States