Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron

Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months

• The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12 months
• Secondary outcomes include analysis of the following parameters: progression of clinical severity by the expanded disability status scale (EDSS score), health related quality of life (HrQoL), and safety.
• Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination, OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire (NEI-VFQ-25) with 10-item supplement.

Inclusion Criteria:

• Have no cognitive impairment that may prevent patient from completing questionnaires, as assessed by examining physicians during screening
• Diagnosis of early (<1 year since onset) RRMS, or a first clinical episode suggestive of demyelinating disease (not explained by other conditions) within the last 90 days prior to screening
• Presence of at least 2 typical MS lesions by brain MRI
• Kurtzke Expanded Disability Status Scale (EDSS) score of 0 - 4.0
• Willing to enroll into the MS Pathways support program and by doing so agree to be trained, and have follow-up phone calls, by a B.E.T.A. nurse

Exclusion Criteria:

• Any disease other than multiple sclerosis that would better explain the patient's neurological signs and symptoms

• Complete transverse myelitis or simultaneous onset of optic neuritis

• Diagnosis of Primary progressive MS, secondary Progressive MS, relapsing progressive MS or a diagnosis of relapsing remitting MS for greater than 12 months

• Clinically significant heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled heart failure

• History of severe, uncontrolled, or untreated depression, attempted suicide or suicidal ideation

• Uncontrolled seizure disorder

• History or hypergammaglobulinemia

• Known hypersensitivity to IFNB-1b or other human proteins including albumin

• Known allergy to Gadolinium-DTPA documented prior to study entry

• Known general hypersensitivity to all analgesic / antiinflammatory agents (NSAIDs)

• Participation in any MS clinical study within the past six months

• Pre-treatment with any of the following substances prior to study enrollment within said time period:

  • At any time: any IFN, glatiramer acetate (Copaxone), total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (i.e. anti-CD4, anti-CD52 (alemtuzumab), anti-VLA4 (natalizumab), mitoxantrone, cyclophosphamide, azathioprine, IVIG, cyclosporine A, methotrexate, or any other immunomodulating or immunosuppressive agent including other recombinant or non-recombinant cytokines
  • 3 months prior to study entry: any other treatment known to be used for putative or experimental MS treatment. Any presumed immunomodulating agent (e.g. statins) not described in this protocol

• History of alcohol or substance abuse (within the past 5 years)

• Inability or unwillingness to administer subcutaneous injections either by self or by caregiver

• Clinically significant hepatic, renal, or bone marrow dysfunction as defined by any of the following laboratory evaluations:

  • Hepatic dysfunction: AST (SGOT) > 3x the upper limit of normal or total bilirubin > 2x upper limit of normal
  • Renal dysfunction: creatinine > 1.8 mg/dl
  • Bone marrow dysfunction: Hb < 8.5 g/dl, WBC < 2.5x10^9/L, or platelet count < 125x10^9/L

• Patients participating in the exploratory substudy should be excluded if they meet any of the following:

  • Known history of chronic glaucoma, ocular hypertension, ischemic optic neuropathy, temporal arteritis, pseudopapilledema, retinitis pigmentosa, traumatic optic neuropathy, toxic optic neuropathy, pernicious anemia, or Leber's hereditary optic neuritis