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Pregnancy Exposure Registry for AVONEX

This study is currently recruiting participants.
Verified by Biogen Idec, August 2008

Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00168714
  Purpose

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   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Pregnancy Exposure Registry for AVONEX

Further study details as provided by Biogen Idec:

Biospecimen Retention:   None Retained

Biospecimen Description:

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)

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Pregnant women with MS who were exposed to Avonex in the US


Criteria

Inclusion Criteria:

  • Have been exposed to AVONEX® within approximately 1 week of conception or during the first trimester of pregnancy.
  • Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively).
  • Provide verbal consent to participate in the Registry.
  • Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168714

Contacts
Contact: Kendle International     (+1) 910-509-4954     registries@kendle.com    
Contact: Biogen Idec     neurologyclinicaltrials@biogenidec.com    

Locations
United States, North Carolina
Kendle     Recruiting
      Wilmington, North Carolina, United States, 28405
      Contact: Fax: 1-800-800-1052     910-509-4954     registries@kendle.com    

Sponsors and Collaborators
Biogen Idec

Investigators
Study Chair:     Kendle Study Chair     Kendle    
Study Director:     Biogen Idec, MD     Biogen Idec    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by Biogen Idec:
Pregnancy  
AVONEX  

Study placed in the following topic categories:
Pregnancy Complications
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Prenatal Exposure Delayed Effects

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Prenatal Injuries
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2008




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