Clinical trial NCT00461396: Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing-Remitting Multiple Sclerosis
First demyelinating event
MRI features consistent with MS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.


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

Primary outcomes:
measure: Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
timeFrame: 12 months
Secondary outcomes:
measure: Extended Disability Status Scale (EDSS)
timeFrame: 12 months
measure: Functional Assessment in Multiple Sclerosis (FAMS)
timeFrame: 12 months
measure: Cytokine and neurotrophic factor production
timeFrame: 12 months
measure: Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)
timeFrame: 18 months
Other outcomes:
Locations:
city: Many Locations
country: United States
state: Alabama
city: Many Locations
country: United States
state: Arizona
city: Many Locations
country: United States
state: Delaware
city: Many Locations
country: United States
state: District of Columbia
city: Many Locations
country: United States
state: Florida
city: Many Locations
country: United States
state: Georgia
city: Many Locations
country: United States
state: Illinois
city: Many Locations
country: United States
state: Iowa
city: Many Locations
country: United States
state: Louisiana
city: Many Locations
country: United States
state: Maine
city: Many Locations
country: United States
state: Minnesota
city: Many Locations
country: United States
state: Missouri
city: Many Locations
country: United States
state: New Jersey
city: Many Locations
country: United States
state: New York
city: Many Locations
country: United States
state: North Carolina
city: Many Locations
country: United States
state: Ohio
city: Many Locations
country: United States
state: Pennsylvania
city: Many Locations
country: United States
state: Tennessee
city: Many Locations
country: United States
state: West Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: