Immunogenicity and Safety of Subcutaneously-Administered Avonex (Interferon Beta 1-a) in Multiple Sclerosis (MS) Subjects

This study has been terminated.
(Company Decision)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00784836
First received: October 29, 2008
Last updated: January 16, 2009
Last verified: January 2009
  Purpose

This study is being conducted to determine the immunogenicity and safety of Avonex (Interferon Beta 1-a) 30 mcg when administered subcutaneously (SC) once weekly to interferon-naive subjects.


Condition Intervention Phase
Multiple Sclerosis
Drug: Avonex
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex (Interferon Beta-1a) 30 Mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Clinical Laboratory Values, Antibodies & Adverse Events [ Time Frame: All Visits - Approx. every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Each subject enrolled in this study will administer 30 mcg of Avonex Subcutaneously once a week, for 18 months.
Drug: Avonex
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.

  Eligibility

Ages Eligible for Study:   18 Years to 60 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) in accordance with national and local subject privacy regulations.
  • Male or Female aged 18 to 60 years old, inclusive, at the time of informed consent.
  • Must have a diagnosis of relapsing MS.
  • Must have a screening EDSS score between 0 and 6.0, inclusive.
  • All male subjects and female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of Avonex.

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions.
  • Diagnosed with Primary progressive, secondary progressive, or progressive relapsing MS.
  • Known allergy to any component of the Avonex formulation.
  • History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
  • Subjects with history of malignant disease, including solid tumors and hematologic malignancies.
  • History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Day 1.
  • 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.
  • Clinically significant abnormal ECG values as determined by the Investigator.
  • Known history of, or a positive test result for, human immunodeficiency virus (HIV).
  • Known history of, or a positive test result for hepatitis C virus.
  • 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 or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
  • Total white blood cell count (WBC)<3700 cells/mm
  • Platelet count<150,000 cells/mm
  • Hemoglobin<10g/dL in female subjects; <11g/dL in male subjects
  • Serum creatinine>ULN
  • Prothrombin time (PT) or activated partial thromboplastin time (aPTT)>1.2xULN
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784836

Locations
United States, Texas
MS Center at Texas Neurology
Dallas, Texas, United States, 75214
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT00784836     History of Changes
Other Study ID Numbers: 108MS303
Study First Received: October 29, 2008
Last Updated: January 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Biogen Idec:
Multiple Sclerosis - Relapsing

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
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 16, 2014