J W Lindsey1, T F Scott2, S G Lynch3, S S Cofield4, F Nelson5, R Conwit6, T Gustafson7, G R Cutter4, J S Wolinsky5, F D Lublin7. 1. 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. 2. Department of Neurology, Drexel College of Medicine, Pittsburgh, PA, USA. 3. Department of Neurology, Kansas University Medical Center, Kansas City, KS, USA. 4. Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA. 5. Department of Neurology, University of Texas Health Science Center at Houston, 6431 Fannin St, Suite 7.044, Houston, TX 77030, USA. 6. National Institute for Neurological Disease and Stroke, National Institutes of Health, Bethesda, MD, USA. 7. Corinne Goldsmith Dickinson Center for Multiple Sclerosis, The Friedman Brain Institute, Mount Sinai School of Medicine, New York, NY, USA.
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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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: Fred D Lublin; Stacey S Cofield; Gary R Cutter; Tarah Gustafson; Stephen Krieger; Ponnada A Narayana; Flavia Nelson; Amber R Salter; Jerry S Wolinsky Journal: Mult Scler Relat Disord Date: 2017-09-23 Impact factor: 4.339
Authors: Ponnada A Narayana; Ivan Coronado; Sheeba J Sujit; Jerry S Wolinsky; Fred D Lublin; Refaat E Gabr Journal: Radiology Date: 2019-12-17 Impact factor: 11.105
Authors: Koushik A Govindarajan; Sushmita Datta; Khader M Hasan; Sangbum Choi; Mohammad H Rahbar; Stacey S Cofield; Gary R Cutter; Fred D Lublin; Jerry S Wolinsky; Ponnada A Narayana Journal: Hum Brain Mapp Date: 2015-06-19 Impact factor: 5.038
Authors: Guoqiao Wang; Gary R Cutter; Stacey S Cofield; Fred Lublin; Jerry S Wolinsky; Tarah Gustafson; Stephen Krieger; Amber Salter Journal: Mult Scler Date: 2016-09-28 Impact factor: 6.312
Authors: Ponnada A Narayana; Ivan Coronado; Sheeba J Sujit; Jerry S Wolinsky; Fred D Lublin; Refaat E Gabr Journal: J Magn Reson Imaging Date: 2019-10-18 Impact factor: 4.813
Authors: Francesca Bovis; Tomas Kalincik; Fred Lublin; Gary Cutter; Charles Malpas; Dana Horakova; Eva Kubala Havrdova; Maria Trojano; Alexandre Prat; Marc Girard; Pierre Duquette; Marco Onofrj; Alessandra Lugaresi; Guillermo Izquierdo; Sara Eichau; Francesco Patti; Murat Terzi; Pierre Grammond; Roberto Bergamaschi; Patrizia Sola; Diana Ferraro; Serkan Ozakbas; Gerardo Iuliano; Cavit Boz; Raymond Hupperts; Francois Grand'Maison; Celia Oreja-Guevara; Vincent van Pesch; Elisabetta Cartechini; Thor Petersen; Ayse Altintas; Aysun Soysal; Cristina Ramo-Tello; Pamela McCombe; Recai Turkoglu; Helmut Butzkueven; Jerry S Wolinsky; Claudio Solaro; Maria Pia Sormani Journal: Neurology Date: 2020-10-06 Impact factor: 9.910