Pregnancy Exposure Registry for Tysabri®
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||52 Weeks|
|Official Title:||TYSABRI® Pregnancy Exposure Registry|
- Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
- Number of elective or therapeutic pregnancy terminations [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
- Number of Live Births [ Time Frame: 4 weeks after the estimated date of delivery ] [ Designated as safety issue: Yes ]
- Number of Live Births with Birth Defects [ Time Frame: 8-12 weeks post-birth ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472992
|United States, West Virginia|
|United BioSource Corporation|
|Morgantown, West Virginia, United States, 26505|
|Study Director:||Medical Director||Biogen Idec|