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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: BG9418 (interferon beta 1-a)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avonex<br>Avonex 30 mcg given subcutaneously, once weekly, for 18 months. | Drug: BG9418 (interferon beta 1-a)<br> <br> * Other names: Avonex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | assessed every 3 months up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Planned for up to 18 months plus 30 days; actual study duration was 111 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis - Relapsing