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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00461396
First received: April 17, 2007
Last updated: April 7, 2011
Last verified: April 2011
  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.

Condition Intervention
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Drug: Interferon-1beta (Betaseron, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extended Disability Status Scale (EDSS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Functional Assessment in Multiple Sclerosis (FAMS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cytokine and neurotrophic factor production [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: May 2007
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461396

  Show 19 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00461396     History of Changes
Other Study ID Numbers: 14465, 311501, BF0713US
Study First Received: April 17, 2007
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Relapsing-Remitting Multiple Sclerosis
First demyelinating event
MRI features consistent with MS

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014