Multiple Sclerosis

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):

Gary Cutter, PhD
Department of Biostatistics
University of Alabama at Birmingham
Room 410B
Ryals Public Health Building
1665 University Boulevard
Birmingham, AL 35294-0022
Director
Stacey Cofield, PhD
Department of Biostatistics
University of Alabama at Birmingham
Room 410C
Ryals Public Health Building
1665 University Boulevard
Birmingham, AL 35294-0022
Deputy Director
Steve Powell, PhD
Department of Biostatistics
University of Alabama at Birmingham
Room 514F
Ryals Public Health Building
1665 University Boulevard
Birmingham, AL 35294-0022
Program Manager

North American Research Consortium on MS (NARCOMS)
 

In 1993, the Consortium of Multiple Sclerosis Centers initiated the NARCOMS Project.  In the 20 years since its inception, the NARCOMS Patient Registry has set 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.

The NARCOMS Vision:
To improve clinical care and quality of life for persons with multiple sclerosis and their families through increased knowledge about MS.
 
  • To conduct epidemiological and health services research in multiple sclerosis.
  • To support new investigators and facilitate exploration of emerging research areas, as well as collaborative multi-center research focused on multiple sclerosis, its treatment and prevention.

        Goals:

       Patient

  • Increase understanding of MS from the perspective of the person with MS

    Disease Management
  • Assess knowledge of treatment and healthcare services, including expected and unexpected consequences thereof

    Knowledge Transfer
  • Disseminate knowledge and increase awareness of MS and its management ot patients, their families care providers, researchers, advocacy groups, and policymakers
      We will achieve these goals by:
  • Providing a distinct mechanism for persons with MS to voluntarily participate in research that supports the NARCOMS Vision.
  • Fostering collaborations between researchers, persons with MS, and healthcare providers within NARCOMS, with the CMSC, and the research community at large.
  • Publishing and presenting research findings to research, clinical and lay communities, and other interested parties.
The NARCOMS Project began in 1993 in Denver, Colorado,  under the auspices of the Consortium of Multiple Sclerosis Centers (CMSC) with the goal of facilitating multiple sclerosis (MS)-related research. The product of this project was the development of a patient self-report registry, which began enrolling participants in 1996 as part of the Yale MS Patient Registry and in 1997 under its own institutional review board (IRB) protocol.
 
Individuals with MS are invited to enroll in the registry through direct mailings, MS centers, support groups and the CMSC/NARCOMS registry webpage.  
NARCOMS Today
As of February 2012, the number of Registry participants has reached over 36,000 and new participants are joining every day.