Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828204
• Other study ID #: 108MS302
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2009
• Last updated: May 8, 2014
• Start date: January 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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]).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• single-use autoinjector with a prefilled liquid Avonex syringe

• Avonex prefilled syringe via manual IM injection

Drug:
• BG9418 (interferon beta-1a)

Locations

Country	Name	City	State
United States	Neurology & Neuroscience Associates, Inc.	Akron	Ohio
United States	Research Site	Atlanta	Georgia
United States	Research Site	Boston	Massachusetts
United States	Research Site	Buffalo	New York
United States	Research Site	Charleston	West Virginia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Dallas	Texas
United States	Michigan Institute for Neurological Disorders	Farmington Hills	Michigan
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Research Site	Gilbert	Arizona
United States	Research Site	Maitland	Florida
United States	Comprehensive Multiple Sclerosis Care Center	Patchogue	New York
United States	Research Site	Phoenix	Arizona
United States	Research Site	Richmond	Virginia
United States	Research Site	Round Rock	Texas
United States	Research Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector	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.	Day 23	No
Other	Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector	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.	Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)	Yes
Other	Mean Score for Ease of Use Grading Scale	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).	Day 1, Day 8, Day 15, Day 22	No
Other	Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective	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.	Day 8, Day 15, Day 22	No
Other	Mean Score for Initial Subset on Autoinjector Instructions Grading Scale	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).	Day 8	No
Other	Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector	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.	Day 1, Day 8, Day 15, Day 22	No
Other	Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe	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?	Day 23	No
Other	Mean Pain Score After Injection	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).	Day 1, Day 8, Day 15, Day 22	Yes
Primary	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	No