Pregnancy Exposure Registry for AVONEX

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00168714
First received: September 9, 2005
Last updated: September 29, 2011
Last verified: September 2011
  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
Prenatal Exposure Delayed Effects
Multiple Sclerosis
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy Exposure Registry for AVONEX

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • birth defects and spontaneous fetal losses [ Time Frame: prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy ] [ Designated as safety issue: Yes ]
  • record and analyze pregnancy outcomes [ Time Frame: prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: February 2004
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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

Locations
United States, North Carolina
Kendle
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00168714     History of Changes
Other Study ID Numbers: C-871
Study First Received: September 9, 2005
Last Updated: September 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Biogen Idec:
AVONEX
Pregnancy

Additional relevant MeSH terms:
Multiple Sclerosis
Prenatal Exposure Delayed Effects
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Prenatal Injuries
Pregnancy Complications
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014