Status
Conditions
About
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.
Full 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.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
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, as follows:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Data sourced from clinicaltrials.gov
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