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Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168714
First Posted: September 15, 2005
Last Update Posted: June 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.

Condition Intervention
Prenatal Exposure Delayed Effects Multiple Sclerosis Pregnancy Drug: BG9418 (interferon beta-1a)

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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Record and analyze 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 ]
  • 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 ]

Enrollment: 329
Study Start Date: February 2004
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant participants
Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy
Drug: BG9418 (interferon beta-1a)
Exposure to Avonex during pregnancy
Other Name: Avonex

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Key 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).

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168714


Locations
United States, North Carolina
Kendle
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00168714     History of Changes
Other Study ID Numbers: C-871
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: June 9, 2014
Last Verified: June 2014

Keywords provided by Biogen:
AVONEX
Pregnancy

Additional relevant MeSH terms:
Multiple Sclerosis
Prenatal Exposure Delayed Effects
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Prenatal Injuries
Pregnancy Complications
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic


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