Pregnancy Exposure Registry for Tysabri

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Biogen Idec
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00472992
First received: May 11, 2007
Last updated: July 26, 2012
Last verified: July 2012

May 11, 2007
July 26, 2012
January 2007
June 2016   (final data collection date for primary outcome measure)
Pregnancy Outcomes: Spontaneous Abortions, Birth Defects [ Time Frame: same day outcome is known ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00472992 on ClinicalTrials.gov Archive Site
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Pregnancy Exposure Registry for Tysabri
TYSABRI Pregnancy Exposure Registry

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pregnant women with MS or CD who were exposed to Tysabri in the US, Canada, and the Rest of World.

  • Multiple Sclerosis
  • Prenatal Exposure
  • Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2016
June 2016   (final data collection date for primary outcome measure)

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. Patients must be exposed to TYSABRI® within 3 months prior to conception or during pregnancy to be eligible. The outcome of the pregnancy must not be known at the time of enrollment.

Female
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No
Contact: Biogen Idec neurologyclinicaltrials@biogenidec.com
United States
 
NCT00472992
101MS401
No
Biogen Idec MD, Biogen Idec, Inc.
Biogen Idec
Elan Pharmaceuticals
Not Provided
Biogen Idec
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP