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Pregnancy Exposure Registry for Tysabri®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472992
First Posted: May 14, 2007
Last Update Posted: August 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
May 11, 2007
May 14, 2007
August 11, 2014
January 2007
July 2012   (Final data collection date for primary outcome measure)
  • Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies [ Time Frame: Approximately 9 months ]
  • Number of elective or therapeutic pregnancy terminations [ Time Frame: Approximately 9 months ]
  • Number of Live Births [ Time Frame: 4 weeks after the estimated date of delivery ]
  • Number of Live Births with Birth Defects [ Time Frame: 8-12 weeks post-birth ]
Not Provided
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 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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
52 Weeks
Not Provided
Non-Probability Sample
Pregnant women with MS or CD who were exposed to Tysabri® in the US, Canada, and the Rest of World within 90 days prior to their last menstrual period.
  • Crohn's Disease
  • Prenatal Exposure
  • Multiple Sclerosis
  • Pregnancy
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Friend S, Richman S, Bloomgren G, Cristiano LM, Wenten M. Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. 2016 Aug 24;16(1):150. doi: 10.1186/s12883-016-0674-4.
 
Completed
376
July 2012
July 2012   (Final data collection date for primary outcome measure)

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:

  1. Documentation that the patient was exposed to TYSABRI® within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
  2. The outcome of the pregnancy must not be known at the time of enrollment. For pregnancies for which the outcomes are known at the time of enrollment, the information will be collected as retrospective reports and analyzed separately.
  3. For US patients, verbal informed consent must be collected at the time of enrollment. The Coordinating Center (CC) obtains verbal informed consent (if verbal consent has not already been obtained by the physician). The CC then mails the patient a Release of Medical Information form to sign and return. If the patient is a minor, verbal consent must be obtained from the parent or legal guardian and verbal assent must be obtained from the patient.
  4. For Canadian patients, a written informed consent must be collected by the TYGRIS investigator at the time of enrollment. A Release of Medical Information form will also be signed by the patient and returned to the CC.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00472992
101MS401
No
Not Provided
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Biogen
Biogen
Elan Pharmaceuticals
Study Director: Medical Director Biogen
Biogen
August 2014