check_circleStudy Completed

Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

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

Trial purpose

- 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.

Key Participants Requirements

Sex

Both

Age

18 - 50 Years
  • - 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

Trial summary

Enrollment Goal
104
Trial Dates
May 2007 - November 2009
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
United States
Completed
Asheville, 28801, United States
Completed
New Brunswick, 08901, United States
Completed
Teaneck, 07666, United States
Completed
Patchogue, 11772, United States
Completed
Knoxville, 37916, United States
Completed
Golden Valley, 55442, United States
Completed
Columbus, 31907, United States
Completed
Tucson, 85741-3537, United States
Completed
New York, 10003, United States
Completed
Cincinnati, 45219, United States
Completed
Knoxville, 37934, United States
Completed
Cullman, 35058, United States
Completed
St. Petersburg, 33701, United States
Completed
Philadelphia, 19107, United States
Completed
Shreveport, 71103, United States
Completed
Charleston, 25301, United States
Completed
Washington, 20037, United States
Completed
St. Louis, 63141, United States
Completed
Duluth, 55805, United States
Completed
Nashville, 37205, United States
Completed
Atlanta, 30309-1465, United States
Completed
Franklin, 37064, United States
Completed
Des Moines, 50314-2611, United States
Completed
Chicago, 60611, United States
Completed
Winston-Salem, 27157, United States
Completed
Jacksonville, 32209, United States
Completed
Staten Island, 10306, United States
Completed
Amherst, 14226, United States
Completed
Flossmoor, 60422, United States
Completed
Newark, 19713, United States
Completed
Biddeford, 04005, United States
Completed
Allentown, 18104, United States
Completed
Columbia, 65203, United States

Primary Outcome

  • Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Extended Disability Status Scale (EDSS)
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No
  • Functional Assessment in Multiple Sclerosis (FAMS)
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No
  • Cytokine and neurotrophic factor production
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No
  • Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)
    date_rangeTime Frame:
    18 months
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    Safety Issue:
    No

Trial design

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
N/A