Pregnancy Exposure Registry for Tysabri®

Multiple Sclerosis Clinical Trial

Official title:

TYSABRI® Pregnancy Exposure Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472992
• Other study ID #: 101MS401
• Status: Completed
• Phase: N/A
• First received: May 11, 2007
• Last updated: August 7, 2014
• Start date: January 2007
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyCanada: Health CanadaUnited States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	United BioSource Corporation	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies		Approximately 9 months	Yes
Primary	Number of elective or therapeutic pregnancy terminations		Approximately 9 months	Yes
Primary	Number of Live Births		4 weeks after the estimated date of delivery	Yes
Primary	Number of Live Births with Birth Defects		8-12 weeks post-birth	Yes