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

This study has been terminated.
(Terminated early by Sponsor for business reasons unrelated to safety.)
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00784836
First received: October 29, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.


Condition Intervention Phase
Multiple Sclerosis
Drug: BG9418 (interferon beta 1-a)
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 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:
  • Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta) [ Time Frame: assessed every 3 months up to 18 months ] [ Designated as safety issue: No ]
    The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Planned for up to 18 months plus 30 days; actual study duration was 111 days. ] [ Designated as safety issue: Yes ]
    AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.


Enrollment: 3
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avonex
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Drug: BG9418 (interferon beta 1-a)
Other Name: Avonex

  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 Expanded Disability Status Scale (EDSS) score between 0 and 6.0, inclusive.
  • All male subjects and female participants 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 electrocardiogram (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:

    1. 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.
    2. Total white blood cell count (WBC) <3700 cells/mm
    3. Platelet count <150,000 cells/mm
    4. Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects
    5. Serum creatinine >upper limit of normal (ULN)
    6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN
  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: NCT00784836

Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Texas
MS Center at Texas Neurology
Dallas, Texas, United States, 75214
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00784836     History of Changes
Other Study ID Numbers: 108MS303
Study First Received: October 29, 2008
Results First Received: February 17, 2010
Last Updated: April 7, 2014
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 July 24, 2014