NCT00461396CompletedNot Applicable
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 104
- Primary Endpoint
- Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Intervention: Interferon-1beta (Betaseron, BAY86-5046) (Drug)
Outcomes
Primary Outcomes
Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
Time Frame: 12 months
Secondary Outcomes
- Extended Disability Status Scale (EDSS)(12 months)
- Functional Assessment in Multiple Sclerosis (FAMS)(12 months)
- Cytokine and neurotrophic factor production(12 months)
- Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)(18 months)
Investigators
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