success of titration, analgesics, and b.e.t.a nurse support on acceptance rates in early multiple sclerosis (ms) treatment with betaseron

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Summary: * 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.


Eligibility criteria:
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

Keywords: relapsing-remitting multiple sclerosis first demyelinating event mri features consistent with ms