Pregnancy Exposure Registry for Tysabri®

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00472992
Study type	Observational [Patient Registry]
Source	Biogen
Contact
Status	Completed
Phase	N/A
Start date	January 2007
Completion date	July 2012

View Details

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