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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00828204
First received: January 20, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector [ Time Frame: Day 23 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 95
Study Start Date: January 2009
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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]).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828204

Locations
United States, Arizona
Research Site
Gilbert, Arizona, United States, 85234
Research Site
Phoenix, Arizona, United States, 85018
United States, Florida
Research Site
Maitland, Florida, United States, 32751
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30327
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46804
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 2135
United States, Michigan
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States, 28595
United States, New York
Research Site
Buffalo, New York, United States, 14203
Comprehensive Multiple Sclerosis Care Center
Patchogue, New York, United States, 11772
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
United States, Ohio
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States, 4320
United States, Texas
Research Site
Dallas, Texas, United States, 75214
Research Site
Round Rock, Texas, United States, 78681
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84103
United States, Virginia
Research Site
Richmond, Virginia, United States, 23298
United States, West Virginia
Research Site
Charleston, West Virginia, United States, 25301
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00828204     History of Changes
Other Study ID Numbers: 108MS302
Study First Received: January 20, 2009
Results First Received: July 13, 2011
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta 1a
Interferon-beta
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014