Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron
