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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00168714
First received: September 9, 2005
Last updated: June 6, 2014
Last verified: June 2014
  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 Idec:

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 ] [ 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: 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00168714     History of Changes
Other Study ID Numbers: C-871
Study First Received: September 9, 2005
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Biogen Idec:
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
Interferon beta 1a
Interferon-beta
Interferons
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014