Status:
COMPLETED
Betaseron Pregnancy Registry
Lead Sponsor:
Syneos Health
Collaborating Sponsors:
Bayer
Conditions:
Birth Defects
Pregnancy Complications
Eligibility:
FEMALE
Brief Summary
This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or ...
Detailed Description
Because informed consent is required, the Registration process must be initiated by the patient. An HCP who contacts the Registry may request an authorization for release of medical information packet...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The subjects must meet the following criteria for registration:
- Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
- Diagnosed with MS prior to or during the current pregnancy
- Exposed to Betaseron® on or after the first day of the patient's last menstrual period
- Provide verbal consent to participate in the Registry
- Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00317564
Start Date
April 1 2006
End Date
June 1 2012
Last Update
December 12 2018
Active Locations (1)
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1
INC Research
Wilmington, North Carolina, United States, 28405