title: The CombiRx trial of combined therapy with interferon and glatiramer acetate in relapsing remitting MS: Design and baseline characteristics.
abstract: BACKGROUND
  Interferon-β1a (IFNB) and glatiramer acetate (GA) are distinct therapies which are both partially effective for relapsing MS. It is not known if combining the two treatments would be more effective.
  
  
  OBJECTIVE
  To review the rationale, design, and baseline characteristics of the CombiRx study of combined treatment with IFNB and GA.
  
  
  METHODS
  The key inclusion criteria included a diagnosis of relapsing MS, at least 2 episodes of MS activity in the previous 3 years, expanded disability status scale of 0-5.5, and no prior treatment with either IFNB or GA. Subjects were randomized to IFNB+GA, IFNB monotherapy, or GA monotherapy in a 2:1:1 ratio.
  
  
  RESULTS
  From 2005 to 2009, we enrolled 1008 subjects. The participants were 72.4% female and 87.6% Caucasian with a mean age of 37.7 years. The median duration of symptoms was 2 years at entry into the study, and the mean EDSS was 2.1. On the baseline MRI, the mean total lesion load was 12.2ml, and 40% of the participants had enhancing lesions.
  
  
  CONCLUSIONS
  We have recruited a population of patients with clinical and MRI characteristics typical for early MS. The study results will aid in deciding on the optimum early treatment. This trial should serve as a model for future studies of combination therapy.
authors: Department of Neurology, University of Texas Health Science Center at Houston, 6431 Fannin St, Suite 7.044, Houston, TX 77030, USA. Electronic address: John.w.lindsey@uth.tmc.edu.
authors: J W
authors: JW
authors: Lindsey
authors: Department of Neurology, Drexel College of Medicine, Pittsburgh, PA, USA.
authors: T F
authors: TF
authors: Scott
authors: Department of Neurology, Kansas University Medical Center, Kansas City, KS, USA.
authors: S G
authors: SG
authors: Lynch
authors: Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA.
authors: S S
authors: SS
authors: Cofield
authors: Department of Neurology, University of Texas Health Science Center at Houston, 6431 Fannin St, Suite 7.044, Houston, TX 77030, USA.
authors: F
authors: F
authors: Nelson
authors: National Institute for Neurological Disease and Stroke, National Institutes of Health, Bethesda, MD, USA.
authors: R
authors: R
authors: Conwit
authors: Corinne Goldsmith Dickinson Center for Multiple Sclerosis, The Friedman Brain Institute, Mount Sinai School of Medicine, New York, NY, USA.
authors: T
authors: T
authors: Gustafson
authors: Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA.
authors: G R
authors: GR
authors: Cutter
authors: Department of Neurology, University of Texas Health Science Center at Houston, 6431 Fannin St, Suite 7.044, Houston, TX 77030, USA.
authors: J S
authors: JS
authors: Wolinsky
authors: Corinne Goldsmith Dickinson Center for Multiple Sclerosis, The Friedman Brain Institute, Mount Sinai School of Medicine, New York, NY, USA.
authors: F D
authors: FD
authors: Lublin
keywords: Clinical trial; Combination therapy; Glatiramer acetate; Interferon beta-1a; Multiple sclerosis; Randomized