Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: BG9418 (interferon beta 1-a)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis - Relapsing

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.
    

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:

               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