Pregnancy Exposure Registry for Tysabri®

Completed

• Conditions: Multiple Sclerosis; Crohn's Disease; Pregnancy; Prenatal Exposure

• Registration Number: NCT00472992
• Lead Sponsor: Biogen

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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-05-11
• Study First Submitted QC: 2007-05-11
• Study First Posted: 2007-05-14
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 376

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Live Births with Birth Defects	8-12 weeks post-birth
Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies	Approximately 9 months
Number of elective or therapeutic pregnancy terminations	Approximately 9 months
Number of Live Births	4 weeks after the estimated date of delivery

Trial Locations

Locations (1)

United BioSource Corporation; 🇺🇸 Morgantown, West Virginia, United States