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| Sponsors and Collaborators: |
Biogen Idec Elan Pharmaceuticals |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00472992 |
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 |
|---|
|
Pregnancy Prenatal Exposure Delayed Effects Multiple Sclerosis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | TYSABRI Pregnancy Exposure Registry |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | October 2015 |
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 |
Pregnant women with MS who were exposed to Tysabri in the US, Canada, and the Rest of World.
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| Contact: Biogen Idec | neurologyclinicaltrials@biogenidec.com |
| United States, West Virginia | |
| Recruiting | |
| Morgantown, West Virginia, United States | |
| Contact: Fax: 866-718-6927 866-831-2358 LSKC.BiogenIdec.Tysabri@unitedbiosource.com | |
| Study Director: | Biogen Idec | Biogen Idec |
More Information
| Responsible Party: | Biogen Idec, Inc. ( Biogen Idec MD ) |
| Study ID Numbers: | 101MS401 |
| Study First Received: | May 11, 2007 |
| Last Updated: | December 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00472992 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; ROW: European Medicines Evaluation Agency |
|
Pregnancy TYSABRI |
|
Pregnancy Complications Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System Prenatal Exposure Delayed Effects |
|
Pathologic Processes Immune System Diseases Prenatal Injuries Nervous System Diseases |
