Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
|Multiple Sclerosis||Device: single-use autoinjector with a prefilled liquid Avonex syringe Device: Avonex prefilled syringe via manual IM injection Drug: BG9418 (interferon beta-1a)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|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|
- Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector [ Time Frame: Day 22 ]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.
- Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector [ Time Frame: Day 23 ]Number of participants in the Initial Subset who answered yes to the question "Were you satisfied with this single-use injector?" on the Subject Satisfaction Questionnaire.
- Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector [ Time Frame: Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22) ]The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.
- Mean Score for Ease of Use Grading Scale [ Time Frame: Day 1, Day 8, Day 15, Day 22 ]Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).
- Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective [ Time Frame: Day 8, Day 15, Day 22 ]Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.
- Mean Score for Initial Subset on Autoinjector Instructions Grading Scale [ Time Frame: Day 8 ]Participants in the Initial Subset were asked to answer the question "How satisfied are you with the presentation of the autoinjector instructions?" on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied).
- Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector [ Time Frame: Day 1, Day 8, Day 15, Day 22 ]Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: "Did you have any difficulty with your injection?" The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented.
- Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe [ Time Frame: Day 23 ]Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?
- Mean Pain Score After Injection [ Time Frame: Day 1, Day 8, Day 15, Day 22 ]Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).
|Study Start Date:||January 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Avonex Single-Use Autoinjector
Participants 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.
Device: single-use autoinjector with a prefilled liquid Avonex syringe
Device: Avonex prefilled syringe via manual IM injection
Drug: BG9418 (interferon beta-1a)
Other Name: Avonex
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828204
|United States, Arizona|
|Gilbert, Arizona, United States, 85234|
|Phoenix, Arizona, United States, 85018|
|United States, Florida|
|Maitland, Florida, United States, 32751|
|United States, Georgia|
|Atlanta, Georgia, United States, 30327|
|United States, Indiana|
|Fort Wayne Neurological Center|
|Fort Wayne, Indiana, United States, 46804|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 2135|
|United States, Michigan|
|Michigan Institute for Neurological Disorders|
|Farmington Hills, Michigan, United States, 28595|
|United States, New York|
|Buffalo, New York, United States, 14203|
|Comprehensive Multiple Sclerosis Care Center|
|Patchogue, New York, United States, 11772|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|United States, Ohio|
|Neurology & Neuroscience Associates, Inc.|
|Akron, Ohio, United States, 4320|
|United States, Texas|
|Dallas, Texas, United States, 75214|
|Round Rock, Texas, United States, 78681|
|United States, Utah|
|Salt Lake City, Utah, United States, 84103|
|United States, Virginia|
|Richmond, Virginia, United States, 23298|
|United States, West Virginia|
|Charleston, West Virginia, United States, 25301|
|Study Director:||Medical Director||Biogen|