Determine Subject Satisfaction in Using the Single-Use Autoinjector With Pre-Filled Liquid Avonex in Subjects With Multiple Sclerosis - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00828204

Purpose

The study is being conducted to determine subject satisfaction with the Avonex Single-Use Autoinjector.

Condition	Intervention	Phase
Multiple Sclerosis	Other: Single-Use Autoinjector with a Pre-Filled Liquid Avonex Syringe	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta 1a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid Avonex Syringe in Multiple Sclerosis Subjects

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Autoinjector Subject Satisfaction Questionnaire [ Time Frame: Subjects complete questionnaire 2 times during study. Once at Day 23 and once at Day 36. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject Assessments (Injection Site Pain Scale, Ease of Use Grading Scale, Autoinjector Instructions Grading Scale, Clinical Injection Site Assessment and AE Reports). [ Time Frame: Subjects complete different assessments at various times during the study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single-Use Autoinjector with a Pre-Filled Liquid Avonex Syringe All subjects will receive open-label treatment with Avonex 30 mcg, IM once weekly. Subjects will receive one manual injection with a pre-filled Avonex syringe, followed by 3 injections delivered by a Single-Use Autoinjector.	Other: 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:

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)
Male or Female aged 18-65 years old, inclusive, at the time of consent.
Must currently be using Avonex Prefilled Syringes to treat MS and must have been using Avonex Prefilled Syringes for the 12 weeks prior to the screening visit.
Must have a minimum BMI of 19 kg/m, and a minimum body weight of 50 kg at screening.
Must by physically able to self administer Avonex IM injections
Must be able to demonstrate successful operations of the autoinjector device
Must be English Speaking
All male subjects and female subjects of child-bearing potential must practice effective contraception during the study.

Exclusion Criteria:

History of seizure disorder or unexplained blackouts OR history of seizure within 3 months prior to screening.
History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.
Clinically significant local infection or systemic infection at the discretion of the Investigator.
Known history of HIV
Known history of, or positive test result for Hepatitis C virus or Hepatitis B virus and/or Hepatitis B Core Antibody.
Abnormal screening blood tests exceeding any of the limits defined below:
Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal (>2xULN) or bilirubin>1.5xULN.
Total white blood cell count (WBC) <3700 cells/mm
Platelet count <150,000 cells/mm
Hemoglobin<10 g/dL in female subjects; <11 g/dL in male subjects
Serum creatinine>ULN
Prothrombin time (PT) or activated partial thromboplastin time (aPTT)>1.2 x ULN.

Contacts and Locations

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

Locations

United States, Arizona
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, 02135
United States, Michigan
Research Site
Farmington Hills, Michigan, United States, 48334
United States, New York
Research Site
Buffalo, New York, United States, 14203
United States, Texas
Research Site
Dallas, Texas, United States, 75214
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84103
United States, Virginia
Research Site
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec

neurologyclinicaltrials@biogenidec.com

More Information

No publications provided

Responsible Party:	Biogen Idec ( Medical Director )
Study ID Numbers:	108MS302
Study First Received:	January 20, 2009
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00828204 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic

Interferon-beta
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic

Sclerosis
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009