Pregnancy Exposure Registry for Tysabri®

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00472992
First received: May 11, 2007
Last updated: August 7, 2014
Last verified: August 2014

May 11, 2007
August 7, 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 ] [ Designated as safety issue: Yes ]
  • Number of elective or therapeutic pregnancy terminations [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
  • Number of Live Births [ Time Frame: 4 weeks after the estimated date of delivery ] [ Designated as safety issue: Yes ]
  • Number of Live Births with Birth Defects [ Time Frame: 8-12 weeks post-birth ] [ 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 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
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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 within 90 days prior to their last menstrual period.

  • Crohn's Disease
  • Prenatal Exposure
  • Multiple Sclerosis
  • 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.
 
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.

Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00472992
101MS401
No
Biogen Idec
Biogen Idec
Elan Pharmaceuticals
Study Director: Medical Director Biogen Idec
Biogen Idec
August 2014

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