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

NCT00168714 | Completed DMC

• 1 other identifier: C-871
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prenatal Exposure Delayed Effects; Multiple Sclerosis; Pregnancy

Keywords

AVONEX; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Record and analyze birth defects and spontaneous fetal losses

  Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy

• Record and analyze pregnancy outcomes

  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

Study Arms (1)

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)

Interventions

BG9418 (interferon beta-1a) DRUG

Exposure to Avonex during pregnancy

Also known as: Avonex

Pregnant participants

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Kendle

Wilmington, North Carolina, 28405, United States

Location

Related Publications (1)

• Weinstock-Guttman B, Ross AP, Planton J, White K, Pandhi A, Greco A, Kumar A, Everage N, Vignos M. Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX(R) Pregnancy Exposure Registry. Drugs Real World Outcomes. 2023 Dec;10(4):503-511. doi: 10.1007/s40801-023-00384-0. Epub 2023 Sep 22.

  PMID: 37737962 DERIVED

MeSH Terms

Conditions

Prenatal Exposure Delayed Effects; Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Prenatal Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2004
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

US (1)