Status:
COMPLETED
Pregnancy Exposure Registry for Tysabri®
Lead Sponsor:
Biogen
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Crohn's Disease
Prenatal Exposure
Eligibility:
FEMALE
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 pr...
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 Coordina...
Eligibility Criteria
Inclusion
- 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:
- 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).
- 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.
- 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.
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00472992
Start Date
January 1 2007
End Date
July 1 2012
Last Update
August 11 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
United BioSource Corporation
Morgantown, West Virginia, United States, 26505