Trial Condition(s):
Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron (START)
14465
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- 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.
- 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
- 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
Locations | |
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Locations Investigative Site Many locations, United States | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Asheville, United States, 28801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Brunswick, United States, 08901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Teaneck, United States, 07666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Patchogue, United States, 11772 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Knoxville, United States, 37916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Golden Valley, United States, 55442 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 31907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85741-3537 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45219 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Knoxville, United States, 37934 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cullman, United States, 35058 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, United States, 33701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shreveport, United States, 71103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 25301 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Duluth, United States, 55805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30309-1465 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Franklin, United States, 37064 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Des Moines, United States, 50314-2611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Staten Island, United States, 10306 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amherst, United States, 14226 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Flossmoor, United States, 60422 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newark, United States, 19713 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Biddeford, United States, 04005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Allentown, United States, 18104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbia, United States, 65203 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1