Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
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
1 other identifier
interventional
95
1 country
16
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-sclerosis
Started Jan 2009
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
August 9, 2011
CompletedJune 3, 2014
May 1, 2014
1.5 years
January 20, 2009
July 13, 2011
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector
A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.
Day 22
Other Outcomes (8)
Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector
Day 23
Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector
Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)
Mean Score for Ease of Use Grading Scale
Day 1, Day 8, Day 15, Day 22
- +5 more other outcomes
Study Arms (1)
Avonex Single-Use Autoinjector
EXPERIMENTALParticipants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Must be 18 to 65 years old, inclusive, at the time of informed consent.
- 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.
- In the investigator's opinion, subjects must be willing and able to self-administer all injections required by the protocol.
- Must speak English.
- All male subjects and female subjects of child-bearing potential must practice effective contraception during the study.
You may not qualify if:
- History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to the Screening Visit.
- 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.
- Clinically significant local infection (for example cellulitis, abscess) or systemic infection (pneumonia, septicemia), at the discretion of the Investigator.
- Known history of Human Immunodeficiency Virus (HIV).
- 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 \[HBcAb\]).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (16)
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
Related Publications (1)
Phillips JT, Fox E, Grainger W, Tuccillo D, Liu S, Deykin A. An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex(R) prefilled syringe in multiple sclerosis subjects. BMC Neurol. 2011 Oct 14;11:126. doi: 10.1186/1471-2377-11-126.
PMID: 21999176DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Initial Subset is too small a population from which to draw conclusions.
Results Point of Contact
- Title
- Biogen Idec Medical Director
- Organization
- Biogen Idec Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 23, 2009
Study Start
January 1, 2009
Primary Completion
July 1, 2010
Study Completion
October 1, 2010
Last Updated
June 3, 2014
Results First Posted
August 9, 2011
Record last verified: 2014-05