Pregnancy Exposure Registry for Tysabri®

NCT ID: NCT00472992

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 376 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Elan Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

United BioSource Corporation

Morgantown, West Virginia, United States

Countries

United States

References

Friend S, Richman S, Bloomgren G, Cristiano LM, Wenten M. Evaluation of pregnancy outcomes from the Tysabri(R) (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.

Reference Type: DERIVED

PMID: 27552976 (View on PubMed)

Other Identifiers

101MS401

Identifier Type: -

Identifier Source: org_study_id