Back to resultsImmunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BG9418 (interferon beta 1-a)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis - Relapsing
Eligibility 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:
- 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 <10 g/dL in female subjects; <11 g/dL in male subjects
- Serum creatinine >upper limit of normal (ULN)
- Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN
Sites / Locations
- Henry Ford Hospital
- MS Center at Texas Neurology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avonex
Arm Description
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Outcomes
Primary Outcome Measures
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00784836
Brief Title
Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated early by Sponsor for business reasons unrelated to safety.
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis - Relapsing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avonex
Arm Type
Experimental
Arm Description
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Intervention Type
Drug
Intervention Name(s)
BG9418 (interferon beta 1-a)
Other Intervention Name(s)
Avonex
Primary Outcome Measure Information:
Title
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
Description
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.
Time Frame
assessed every 3 months up to 18 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Planned for up to 18 months plus 30 days; actual study duration was 111 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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 <10 g/dL in female subjects; <11 g/dL in male subjects
Serum creatinine >upper limit of normal (ULN)
Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
MS Center at Texas Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
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