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Sponsored by: |
Biogen Idec |
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00168714 |
This is an observational, exposure-registration and follow-up study, which will be conducted in the United States (US). The AVONEX® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses inadvertently exposed to AVONEX® and to detect any potential increase in the risk of major birth defects. It is also designed to detect any potential increase in the risk of spontaneous pregnancy loss. The AVONEX® Pregnancy Exposure Registry is sponsored by Biogen Idec Inc. and will be managed by Kendle, the Registry Data Coordinating Center (DCC). The Registry will be monitored by an independent Advisory Committee consisting of external experts in relevant specialities of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Condition | Phase |
Pregnancy Prenatal Exposure Delayed Effects Multiple Sclerosis |
Phase IV |
MedlinePlus related topics: | Multiple Sclerosis Prenatal Care |
ChemIDplus related topics: | Interferon beta 1a |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Pregnancy Exposure Registry for AVONEX |
Estimated Enrollment: | 300 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Prospective reports will be collected from pregnant subjects, health care providers (HCPs), or Biogen Idec Drug Safety and Risk Management (DSRM) staff. Data from pregnant subjects will be collected at 4 to 5 months of pregnancy and 8 to 12 weeks after the estimated date of delivery (EDD) by telephone interviews with the Registry. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, paper forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 8 to 12 weeks age. If a birth defect is reported, targeted follow-up will be conducted.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pregnant women with MS who were exposed to Avonex in the US
Inclusion Criteria:
Contact: Kendle International | (+1) 910-509-4954 | registries@kendle.com |
Contact: Biogen Idec | neurologyclinicaltrials@biogenidec.com |
United States, North Carolina | |||||
Kendle | Recruiting | ||||
Wilmington, North Carolina, United States, 28405 | |||||
Contact: Fax: 1-800-800-1052 910-509-4954 registries@kendle.com |
Biogen Idec |
Study Chair: | Kendle Study Chair | Kendle |
Study Director: | Biogen Idec, MD | Biogen Idec |
Related Info 
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Responsible Party: | Biogen Idec, Inc. ( Biogen Idec MD ) |
Study ID Numbers: | C-871 |
First Received: | September 9, 2005 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00168714 |
Health Authority: | United States: Institutional Review Board |
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