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

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

• 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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: Interferon-1beta (Betaseron, BAY86-5046)

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Many Locations, Alabama, United States
  • Arizona
    • Many Locations, Arizona, United States
  • Delaware
    • Many Locations, Delaware, United States
  • District of Columbia
    • Many Locations, District of Columbia, United States
  • Florida
    • Many Locations, Florida, United States
  • Georgia
    • Many Locations, Georgia, United States
  • Illinois
    • Many Locations, Illinois, United States
  • Iowa
    • Many Locations, Iowa, United States
  • Louisiana
    • Many Locations, Louisiana, United States
  • Maine
    • Many Locations, Maine, United States
  • Minnesota
    • Many Locations, Minnesota, United States
  • Missouri
    • Many Locations, Missouri, United States
  • New Jersey
    • Many Locations, New Jersey, United States
  • New York
    • Many Locations, New York, United States
  • North Carolina
    • Many Locations, North Carolina, United States
  • Ohio
    • Many Locations, Ohio, United States
  • Pennsylvania
    • Many Locations, Pennsylvania, United States
  • Tennessee
    • Many Locations, Tennessee, United States
  • West Virginia
    • Many Locations, West Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Interferon-1beta (Betaseron, BAY86-5046); Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: April 17, 2007
• First Submitted That Met QC Criteria: April 17, 2007
• First Posted (Estimate): April 18, 2007

Study Record Updates

• Last Update Posted (Estimate): April 8, 2011
• Last Update Submitted That Met QC Criteria: April 7, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Relapsing-Remitting Multiple Sclerosis; First demyelinating event; MRI features consistent with MS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1b
• Other Study ID Numbers: 14465; 311501; BF0713US