check_circleStudy Completed
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Bayer Identifier:
14465
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron
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.
- 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.
Key Participants Requirements
Sex
BothAge
18 - 50 YearsTrial summary
Enrollment Goal
104Trial Dates
May 2007 - November 2009Phase
N/ACould I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | United States | |
Completed | Asheville, 28801, United States | |
Completed | New Brunswick, 08901, United States | |
Completed | Teaneck, 07666, United States | |
Completed | Patchogue, 11772, United States | |
Completed | Knoxville, 37916, United States | |
Completed | Golden Valley, 55442, United States | |
Completed | Columbus, 31907, United States | |
Completed | Tucson, 85741-3537, United States | |
Completed | New York, 10003, United States | |
Completed | Cincinnati, 45219, United States | |
Completed | Knoxville, 37934, United States | |
Completed | Cullman, 35058, United States | |
Completed | St. Petersburg, 33701, United States | |
Completed | Philadelphia, 19107, United States | |
Completed | Shreveport, 71103, United States | |
Completed | Charleston, 25301, United States | |
Completed | Washington, 20037, United States | |
Completed | St. Louis, 63141, United States | |
Completed | Duluth, 55805, United States | |
Completed | Nashville, 37205, United States | |
Completed | Atlanta, 30309-1465, United States | |
Completed | Franklin, 37064, United States | |
Completed | Des Moines, 50314-2611, United States | |
Completed | Chicago, 60611, United States | |
Completed | Winston-Salem, 27157, United States | |
Completed | Jacksonville, 32209, United States | |
Completed | Staten Island, 10306, United States | |
Completed | Amherst, 14226, United States | |
Completed | Flossmoor, 60422, United States | |
Completed | Newark, 19713, United States | |
Completed | Biddeford, 04005, United States | |
Completed | Allentown, 18104, United States | |
Completed | Columbia, 65203, United States |
Primary Outcome
- Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatmentdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Extended Disability Status Scale (EDSS)date_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Functional Assessment in Multiple Sclerosis (FAMS)date_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Cytokine and neurotrophic factor productiondate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)date_rangeTime Frame:18 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A