The CombiRx clinical trial is a randomized, double blind, placebo controlled, multi-center randomized study of the efficacy of combining interferon beta-la (IFN) and glatiramer acetate (GA) compared to either agent alone as primary therapy for relapsing-remitting MS (RR MS). The original funding of this NINDS sponsored project was in November 2003. Initially funding was requested for 40 clinical sites across North America. After funding, and based on consultation with NINDS program staff, the number of planned sites was increased to a target of 80 to improve recruitment. The recruitment goal is 1000 subjects, randomized 50% to combination therapy and 25% to each single therapeutic agent with a matched placebo. This application is for renewal of this grant to complete the follow up of all patients through three years on study protocol. The primary outcome and other outcome measures are unchanged from the original protocol and we have expanded the analyses to better assess disability progression. The continuation plan, which is to follow all subjects in their original study arm until the last subject has completed all three years of the study, has been approved by the study DSMB as well as the investigators.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01NS045719-06
Application #
7527525
Study Section
Special Emphasis Panel (ZNS1-SRB-G (26))
Program Officer
Utz, Ursula
Project Start
2003-04-01
Project End
2012-11-30
Budget Start
2009-06-15
Budget End
2009-11-30
Support Year
6
Fiscal Year
2009
Total Cost
$10,100,000
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Neurology
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
Lublin, Fred D; Cofield, Stacey S; Cutter, Gary R et al. (2017) Long-term follow-up of a randomized study of combination interferon and glatiramer acetate in multiple sclerosis: Efficacy and safety results up to 7 years. Mult Scler Relat Disord 18:95-102
Wang, Guoqiao; Cutter, Gary R; Cofield, Stacey S et al. (2017) Baseline EDSS proportions in MS clinical trials affect the overall outcome and power: A cautionary note. Mult Scler 23:982-987
Datta, Sushmita; Staewen, Terrell D; Cofield, Stacy S et al. (2015) Regional gray matter atrophy in relapsing remitting multiple sclerosis: baseline analysis of multi-center data. Mult Scler Relat Disord 4:124-36
Govindarajan, Koushik A; Datta, Sushmita; Hasan, Khader M et al. (2015) Effect of in-painting on cortical thickness measurements in multiple sclerosis: A large cohort study. Hum Brain Mapp 36:3749-3760
Bhanushali, Minal J; Gustafson, Tarah; Powell, Steve et al. (2014) Recruitment of participants to a multiple sclerosis trial: the CombiRx experience. Clin Trials 11:159-66
Tutuncu, Melih; Tang, Junger; Zeid, Nuhad Abou et al. (2013) Onset of progressive phase is an age-dependent clinical milestone in multiple sclerosis. Mult Scler 19:188-98
Morgan, Charity J; Ranjan, Ashutosh; Aban, Inmaculada B et al. (2013) The magnetic resonance imaging 'rule of five': predicting the occurrence of relapse. Mult Scler 19:1760-4
Lublin, Fred D; Cofield, Stacey S; Cutter, Gary R et al. (2013) Randomized study combining interferon and glatiramer acetate in multiple sclerosis. Ann Neurol 73:327-40
Naismith, Robert T; Xu, Junqian; Tutlam, Nhial T et al. (2012) Diffusion tensor imaging in acute optic neuropathies: predictor of clinical outcomes. Arch Neurol 69:65-71
Narayana, Ponnada A; Govindarajan, Koushik A; Goel, Priya et al. (2012) Regional cortical thickness in relapsing remitting multiple sclerosis: A multi-center study. Neuroimage Clin 2:120-31

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