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Pregnancy Exposure Registry for Tysabri®

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ClinicalTrials.gov Identifier: NCT00472992
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : August 11, 2014
Elan Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease
Crohn's Disease Prenatal Exposure Multiple Sclerosis Pregnancy

Detailed Description:

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.

Study Type : Observational [Patient Registry]
Actual Enrollment : 376 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 52 Weeks
Official Title: TYSABRI® Pregnancy Exposure Registry
Study Start Date : January 2007
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Primary Outcome Measures :
  1. Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies [ Time Frame: Approximately 9 months ]
  2. Number of elective or therapeutic pregnancy terminations [ Time Frame: Approximately 9 months ]
  3. Number of Live Births [ Time Frame: 4 weeks after the estimated date of delivery ]
  4. Number of Live Births with Birth Defects [ Time Frame: 8-12 weeks post-birth ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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 within 90 days prior to their last menstrual period.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472992

United States, West Virginia
United BioSource Corporation
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Elan Pharmaceuticals
Study Director: Medical Director Biogen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00472992     History of Changes
Other Study ID Numbers: 101MS401
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Keywords provided by Biogen:

Additional relevant MeSH terms:
Multiple Sclerosis
Crohn Disease
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs