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
|