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

Multiple Sclerosis Clinical Trial

— START  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461396
• Other study ID #: 14465
• Secondary ID: 311501BF0713US
• Status: Completed
• Phase: N/A
• First received: April 17, 2007
• Last updated: April 7, 2011
• Start date: May 2007
• Est. completion date: November 2009

Study information

• Verified date: April 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment		12 months	No
Secondary	Extended Disability Status Scale (EDSS)		12 months	No
Secondary	Functional Assessment in Multiple Sclerosis (FAMS)		12 months	No
Secondary	Cytokine and neurotrophic factor production		12 months	No
Secondary	Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)		18 months	No

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