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

NCT ID: NCT00828204

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-10-31

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

single-use autoinjector with a prefilled liquid Avonex syringe

Intervention Type: DEVICE

Avonex prefilled syringe via manual IM injection

Intervention Type: DEVICE

BG9418 (interferon beta-1a)

Intervention Type: DRUG

Interventions

single-use autoinjector with a prefilled liquid Avonex syringe

Intervention Type: DEVICE

Avonex prefilled syringe via manual IM injection

Intervention Type: DEVICE

BG9418 (interferon beta-1a)

Intervention Type: DRUG

Other Intervention Names

Avonex

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]).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Gilbert, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Maitland, Florida, United States

Research Site

Atlanta, Georgia, United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Research Site

Boston, Massachusetts, United States

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, United States

Research Site

Buffalo, New York, United States

Comprehensive Multiple Sclerosis Care Center

Patchogue, New York, United States

Research Site

Charlotte, North Carolina, United States

Neurology & Neuroscience Associates, Inc.

Akron, Ohio, United States

Research Site

Dallas, Texas, United States

Research Site

Round Rock, Texas, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Richmond, Virginia, United States

Research Site

Charleston, West Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21999176 (View on PubMed)

Other Identifiers

108MS302

Identifier Type: -

Identifier Source: org_study_id