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