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:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00828204
First received: January 20, 2009
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

The main purpose of the study is to find out if patients with Multiple Sclerosis (MS) can safely and effectively use the single-use autoinjector to give their weekly intramuscular (IM) injections of Avonex® (interferon beta-1a).


Condition Intervention Phase
Multiple Sclerosis
Device: Single-Use Autoinjector with a Pre-Filled Liquid Avonex Syringe
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:
  • Proportion of Subjects in the Main Subset With no Failures Occurring in Any Step During the Subject's Use of the Avonex Single-Use Autoinjector. [ Time Frame: Outcome was assessed at Day 22 ] [ Designated as safety issue: Yes ]
    Primary outcome measure was from data captured in the Observation Form that was to be completed by the Trainer/Observer who documented the patient's ability to self-inject with the Avonex single-use autoinjector. Steps and/or actions in the Observation Form were pre-defined as optimal, non-optimal, or failure. Failure was defined as completing the step/action incorrectly, improperly, or in a non-optimal manner that resulted in adverse outcome, resulting in the subject sustaining an injury or the device becoming unusable/nonfunctional for injection, or a possible device malfunction.


Secondary Outcome Measures:
  • Mean Score for Ease of Use Grading Scale. [ Time Frame: Day 8, Day 15, Day 22 ] [ Designated as safety issue: No ]
    Subjects scored the ease of use of the Avonex single-use autoinjector using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).

  • Proportion of Subjects Who Rated the Avonex Single-use Autoinjector Printed Training Materials as Very Effective. [ Time Frame: Day 8, Day 15, Day 22 ] [ Designated as safety issue: No ]
    Subjects evaluated how effective the printed instructions were in educating how to use the Avonex single-use autoinjector. Subjects could choose one the the following possible answers: Not effective at all, somewhat effective, neutral, somewhat effective, and very effective.

  • Proportion of Subjects Who Indicated no Difficulty With the Injection Procedure of the Avonex Single-use Autoinjector. [ Time Frame: Day 8, Day 15, Day 22 ] [ Designated as safety issue: Yes ]
    Subjects evaluted if they had experienced any diffculty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector. Subjects answered yes or no to the following question: Did you have any difficulty with your injection?

  • Proportion of Subjects in the Main Subset 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 ]
    Subjects could answer yes or no to whether they preferred using the Avonex single-use autoinjector over the manual Avonex Prefilled Syringe. Preference was defined as subjects answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?

  • Mean Pain Score After Injection With the Avonex Single-use Autoinjector. [ Time Frame: Day 8, Day 15, Day 22 ] [ Designated as safety issue: Yes ]
    Subjects scored the pain after the use of the Avonex single-use autoinjector on a scale ranging from 0 to 10. Score of 0 was no pain and a score of 10 was extremely painful.

  • Proportion of Subjects Having no Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector. [ Time Frame: Day 8 to Day 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.


Enrollment: 95
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Avonex Single-Use Autoinjector
Avonex 30 mcg given IM once weekly for 4 weeks in the main study and 12 weeks in the Extension Study.
Device: Single-Use Autoinjector with a Pre-Filled Liquid Avonex Syringe
Avonex 30 mcg given IM, once weekly, for 4 weeks.

  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 be English speaking.
  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
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, Massachusetts
Research Site
Boston, Massachusetts, United States, 2135
United States, New York
Research Site
Buffalo, New York, United States, 14203
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
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
Charlestown, West Virginia, United States, 25301
Sponsors and Collaborators
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: Medical Director, 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: March 29, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014