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
  Purpose

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.


Condition
Multiple Sclerosis
Prenatal Exposure
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TYSABRI Pregnancy Exposure Registry

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Pregnancy Outcomes: Spontaneous Abortions, Birth Defects [ Time Frame: same day outcome is known ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472992

Contacts
Contact: Biogen Idec neurologyclinicaltrials@biogenidec.com

Locations
United States, West Virginia
United BioSource Corporation Recruiting
Morgantown, West Virginia, United States, 26505
Contact    866-831-2358    LSKC.BiogenIdec.Tysabri@unitedbiosource.com   
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00472992     History of Changes
Other Study ID Numbers: 101MS401
Study First Received: May 11, 2007
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada

Keywords provided by Biogen Idec:
Pregnancy
TYSABRI

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014