ADVANCE –Peglylated Avonex

Double Blind Study, placebo controlled


All subjects will receive one injection of either BIIB017 or a placebo every 2 weeks. Injections will be given for up to 2 years (96 weeks). During the first year, some subjects will only receive placebo but after the first year, all subjects will be receiving BIIB017. Pts have 66% chance of receiving drug.

Because BIIB017 is very similar to Avonex®, it is expected that the side effects of BIIB017 in people will be similar to what we have seen with Avonex.

Inclusion Criteria:

 
To be eligible to participate in this study, candidates must meet the following eligibility
criteria at the time of randomization, Day 1:

1. Aged 18 to 55 years old, inclusive, at the time of informed consent.
2. Must have a confirmed diagnosis of relapsing MS, as defined by MacDonald criteria
3. Must have an EDSS score between 0.0 and 5.0.
4. Must have experienced at least 2 relapses that have been medically documented
within the last 3 years with at least one of these relapses having occurred within the
past 12 months prior to randomization (Day 1).
5. Subjects have refused alternative treatments and other available therapies.

Exlusion Criteria:

Medical History
1. Primary progressive, secondary progressive, or progressive relapsing MS
2. Prior treatment with interferon cannot exceed 4 weeks and subjects must have
discontinued interferon treatment 6 months prior to Baseline.
3. History of any clinically significant (as determined by the Investigator) cardiac,
endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
neurologic, dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical trial.
6. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
7. History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline.
8. History of suicidal ideation within 3 months prior to Baseline or an episode of severe depression within 3 months prior to Baseline. Severe depression is defined as an episode of depression that requires hospitalization, or at the discretion of the Investigator.
9. Clinically significant abnormal electrocardiogram (ECG) values as determined by the Investigator.
10. 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 (>2 × ULN) or aspartate
              transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) >2 × ULN
              or bilirubin >1.5 × ULN.
         • Total white blood cell count (WBC) < 3,700 /mm3
         • Absolute Neutrophil Count (ANC) of < 1,500 /mm3
         • Platelet count <150,000 c/mm3
         • Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects
         • Serum creatinine >ULN
         • Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.2 × ULN
11. An MS relapse that has occurred within the 50 days prior to randomization and/or the
subject has not stabilized from a previous relapse prior to randomization (Day 1).
12. Elective surgery scheduled within 2 weeks of randomization (day 1)
13.Treatment with other agents to treat MS symptoms or underlying disease as specified below:

    Agent Time Required off Agent Prior to Baseline

         • Any prior treatment with:
              – Total Lymphoid Irradiation
              – Cladribine
              – T-cell Vaccine
              – Natalizumab
              – Rituximab
              – BIIB017

         • Prior treatment within 1 year of randomization:
              – Cyclophosphamide
              – Mitoxantrone

         • Prior treatment within 6 months prior to randomization:
              – Cyclosporin
              – Plasma exchange
              – Intravenous immunoglobulin (IVIg)
              – Azathioprine
              – Methotrexate
 
         • Prior treatment with interferon exceeding 4 weeks and subjects must have discontinued interferon treatment 6 months prior            to randomization

         • Prior treatment within 50 days prior to randomization
              – Systemic corticosteroids

         • Prior treatment with Copaxone within 4 weeks prior to randomization

         • Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to                     randomization

14. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization (Day 1).