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Evaluate the Safe and Effective Use of the Avonex� Single-Use Autoinjector in Multiple Sclerosis Subjects

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: single-use autoinjector with a prefilled liquid Avonex syringe (Device); Avonex prefilled syringe via manual IM injection (Device); BG9418 (interferon beta-1a) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

The primary objective of the study was to evaluate the safe and effective use of the single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex (interferon beta-1a) in participants with multiple sclerosis (MS).

Clinical Details

Official title: An Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex Prefilled Syringe in Multiple Sclerosis Subjects

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector

Detailed description: The Main Study was a 4-week treatment period which consisted of 1 Avonex manual injection using a prefilled syringe, followed by 3 Avonex injections using the single-use autoinjector. The Extension Study was designed to provide continuation of treatment with the Avonex single-use autoinjector to eligible participants who completed the Main Study for up to an additional 12 weeks, and to obtain additional safety and preference data for the Avonex single-use autoinjector. Participants were enrolled under the initial study protocol (Initial Subject Subset); the study was subsequently suspended. Changes were made to the protocol (including modifications to the autoinjector needle), and additional participants were enrolled (Main Subject Subset).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Must be 18 to 65 years old, inclusive, at the time of informed consent. 3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the Screening Visit. 4. In the investigator's opinion, subjects must be willing and able to self-administer all injections required by the protocol. 5. Must speak English. 6. All male subjects and female subjects of child-bearing potential must practice effective contraception during the study. Exclusion Criteria: 1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to the Screening Visit. 2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1. Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy. NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the study unless the dose has been increased within the 3 months prior to the Screening Visit. 3. Clinically significant local infection (for example cellulitis, abscess) or systemic infection (pneumonia, septicemia), at the discretion of the Investigator. 4. Known history of Human Immunodeficiency Virus (HIV). 5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).

Locations and Contacts

Research Site, Gilbert, Arizona 85234, United States

Research Site, Phoenix, Arizona 85018, United States

Research Site, Maitland, Florida 32751, United States

Research Site, Atlanta, Georgia 30327, United States

Fort Wayne Neurological Center, Fort Wayne, Indiana 46804, United States

Research Site, Boston, Massachusetts 2135, United States

Michigan Institute for Neurological Disorders, Farmington Hills, Michigan 28595, United States

Research Site, Buffalo, New York 14203, United States

Comprehensive Multiple Sclerosis Care Center, Patchogue, New York 11772, United States

Research Site, Charlotte, North Carolina 28207, United States

Neurology & Neuroscience Associates, Inc., Akron, Ohio 4320, United States

Research Site, Dallas, Texas 75214, United States

Research Site, Round Rock, Texas 78681, United States

Research Site, Salt Lake City, Utah 84103, United States

Research Site, Richmond, Virginia 23298, United States

Research Site, Charleston, West Virginia 25301, United States

Additional Information

Starting date: January 2009
Last updated: May 8, 2014

Page last updated: August 20, 2015

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