Clinical trial NCT00828204: Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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).

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 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 \[HBcAb\]).

Primary outcomes:
measure: Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector
timeFrame: Day 22
Secondary outcomes:
Other outcomes:
measure: Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector
timeFrame: Day 23
measure: Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector
timeFrame: Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)
measure: Mean Score for Ease of Use Grading Scale
timeFrame: Day 1, Day 8, Day 15, Day 22
measure: Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective
timeFrame: Day 8, Day 15, Day 22
measure: Mean Score for Initial Subset on Autoinjector Instructions Grading Scale
timeFrame: Day 8
measure: Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector
timeFrame: Day 1, Day 8, Day 15, Day 22
measure: Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe
timeFrame: Day 23
measure: Mean Pain Score After Injection
timeFrame: Day 1, Day 8, Day 15, Day 22
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders
state: Michigan
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Patchogue
country: United States
facility: Comprehensive Multiple Sclerosis Care Center
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Neurology & Neuroscience Associates, Inc.
state: Ohio
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Charleston
country: United States
facility: Research Site
state: West Virginia
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.