Trial Condition(s):

Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

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

Bayer Identifier:

14465

ClinicalTrials.gov Identifier:

NCT00461396

EudraCT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
104
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, United States

Status
Completed
 
Locations

Investigative Site

Asheville, United States, 28801

Status
Completed
 
Locations

Investigative Site

New Brunswick, United States, 08901

Status
Completed
 
Locations

Investigative Site

Teaneck, United States, 07666

Status
Completed
 
Locations

Investigative Site

Patchogue, United States, 11772

Status
Completed
 
Locations

Investigative Site

Knoxville, United States, 37916

Status
Completed
 
Locations

Investigative Site

Golden Valley, United States, 55442

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 31907

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85741-3537

Status
Completed
 
Locations

Investigative Site

New York, United States, 10003

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45219

Status
Completed
 
Locations

Investigative Site

Knoxville, United States, 37934

Status
Completed
 
Locations

Investigative Site

Cullman, United States, 35058

Status
Completed
 
Locations

Investigative Site

St. Petersburg, United States, 33701

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19107

Status
Completed
 
Locations

Investigative Site

Shreveport, United States, 71103

Status
Completed
 
Locations

Investigative Site

Charleston, United States, 25301

Status
Completed
 
Locations

Investigative Site

Washington, United States, 20037

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63141

Status
Completed
 
Locations

Investigative Site

Duluth, United States, 55805

Status
Completed
 
Locations

Investigative Site

Nashville, United States, 37205

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30309-1465

Status
Completed
 
Locations

Investigative Site

Franklin, United States, 37064

Status
Completed
 
Locations

Investigative Site

Des Moines, United States, 50314-2611

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Completed
 
Locations

Investigative Site

Winston-Salem, United States, 27157

Status
Completed
 
Locations

Investigative Site

Jacksonville, United States, 32209

Status
Completed
 
Locations

Investigative Site

Staten Island, United States, 10306

Status
Completed
 
Locations

Investigative Site

Amherst, United States, 14226

Status
Completed
 
Locations

Investigative Site

Flossmoor, United States, 60422

Status
Completed
 
Locations

Investigative Site

Newark, United States, 19713

Status
Completed
 
Locations

Investigative Site

Biddeford, United States, 04005

Status
Completed
 
Locations

Investigative Site

Allentown, United States, 18104

Status
Completed
 
Locations

Investigative Site

Columbia, United States, 65203

Status
Completed
 

Trial Design