Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinje
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- single-use autoinjector with a prefilled liquid Avonex syringe
- Avonex prefilled syringe via manual IM injection
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector
Day 22
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Avonex Single-Use Autoinjector: Main Subset | 89 percentage of participants | 81–96 | 70 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Avonex Single-Use Autoinjector: Main Subset | 72 | 0 (0.0%) | |
| Avonex Single-Use Autoinjector: Initial Subset | 19 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector
Day 22
Who could take part
MS (type not specified) · 18 to 65
Show the full 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]).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
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History
Started
Jan 2009
Main results due
Jul 2010
Finished
Oct 2010
Results posted
Aug 2011