Multiple Sclerosis
- COMBI
- North American Research Consortium on MS(NARCOMS)
- Effect of single vs combination therapy on contrast letter acuity in Multiple Sclerosis patients (Vision Study)
COMBI
This is a Multi-Center Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients with Relapsing Remitting Multiple-Sclerosis (CombiRx-Phase III)
CombiRx is a National Institutes of Health – National Institute for Neurolgical Disorders and Stroke (NIH-NINDS) sponsored multi-centered, double-blind, randomized clinical trial. This trial represents the first federally funded trial to prospectively analyze the long-term progression of relapsing-remitting multiple sclerosis (RR MS) when treated with combined agents and will involve 70+ participating centers and 1000 subjects at sites across the U.S. and Canada. The primary objective of this study is to determine whether combined treatment with interferon beta-1a (INF-b) IM once weekly and glatiramer acetate (GA) SQ daily is more effective than either agent alone in treating RR MS, as determined by reduction in relapse rate. Currently, approximately 120,000 multiple sclerosis patients are receiving one of these disease-modifying agents. However, because these agents provide only a partial amelioration of the risk for additional exacerbations and development of disability, there is a major and continuing need for better therapies. Therefore, a definitive, full-scale, randomized clinical is necessary to determine if the combined use of INF-b and GA is a measurably better therapy than either agent used singly in patients with RR MS.
Staff at the Statistical and Data Management Center (SDMC):
|
Garry Cutter, PhD Department of Biostatistics University of Alabama at Birmingham Room 327 Ryals Public Health Building 1665 University Boulevard Birmingham, AL 35294-0022 |
Director |
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Stacey Cofield, PhD Department of Biostatistics University of Alabama at Birmingham Room 327 Ryals Public Health Building 1665 University Boulevard Birmingham, AL 35294-0022 |
Assistant Director |
| Steve Powell, PhD Department of Biostatistics University of Alabama at Birmingham Room 514 Ryals Public Health Building 1665 University Boulevard Birmingham, AL 35294-0022 |
Project Manager |
| Suzanne Perumean-Cheney, PhD Department of Biostatistics University of Alabama at Birmingham Room 327 Ryals Public Health Building 1665 University Boulevard Birmingham, AL 35294-0022 |
Database Quality Assurance Coordinator |
| Todd Jenkins, MPH Department of Biostatistics University of Alabama at Birmingham Room 327 Ryals Public Health Building 1665 University Boulevard Birmingham, AL 35294-0022 |
Statistician |
| Mike Brascome School of Public Health Dean’s Office University of Alabama at Birmingham Room 127 Ryals Public Health Building 1665 University Boulevard Birmingham, AL 35294-0022 |
Lead Programmer |
North American Research Consortium on MS(NARCOMS)
The NARCOMS Project was initiated in 1993 by the Consortium of Multiple Sclerosis Centers. NARCOMS has developed an MS Patient Registry setting a world standard for data collection. NARCOMS was created to help facilitate multi-center research in the broad field of Multiple Sclerosis. Collaboration between centers of excellence in Multiple Sclerosis is essential for rapid progress in the development of better treatments for MS and for greater understanding of the disease.
As of June 2004, the number of Registry participants has reached over 24,000 and new participants are joining every day.
NARCOMS is a project of the Consortium of Multiple Sclerosis Centers and is supported by grants and in-kind services from United Spinal Association, Paralyzed Veterans Association (PVA), and the National Multiple Sclerosis Society. Additional support has been provided by unrestricted grants from the following pharmaceutical companies: Berlex, Biogen, Immunex, Serono, and Teva Neuroscience.
Personnel:
Gary Cutter , PhD PI
Monika Baier , PhD co-PI
Seidu Inusah, co-PI
Rajani Yadavalli, co-PI
Effect of single vs combination therapy on contrast letter acuity in Multiple Sclerosis patients (Vision Study)
This study is an ancillary study to the NIH, NINDS funded study "A multi-center, double-blind, randomized study comparing the combined use of interferon beta-1a (Avonex) and Glatiramer Acetate (Copaxone) to either agent alone in patients with relapsing-remitting multiple sclerosis (CombiRx02-Phase III)". This ancillary study aims to show that contrast letter acuity is sensitive to treatment over the course of a 3 year clinical trial in treatment naïve patients with relapsing-remitting MS. It also intends to show predictive validity of a vision test for contrast letter acuity by determining whether contrast letter acuity can differentiate severity of the progression of disease (worsening on the EDSS, MSFC, and MRI parameters. Finally, this study examines whether contrast letter acuity provides additional information to the current MSFC. The project is funded by the National Multiple Sclerosis Society (NMSS).
Principal investigator: Monika Baier, Ph.D.