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. The extension 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 #
5U01NS045719-08
Application #
8214725
Study Section
Special Emphasis Panel (ZNS1)
Project Start
Project End
Budget Start
2010-12-01
Budget End
2011-11-30
Support Year
8
Fiscal Year
2011
Total Cost
$250,001
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Type
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
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Wang, Guoqiao; Cutter, Gary R; Cofield, Stacey S et al. (2016) Baseline EDSS proportions in MS clinical trials affect the overall outcome and power: A cautionary note. Mult Scler :1352458516670733
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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
Lindsey, Jw; Scott, Tf; Lynch, Sg et al. (2012) The CombiRx trial of combined therapy with interferon and glatiramer cetate in relapsing remitting MS: Design and baseline characteristics. Mult Scler Relat Disord 1:81-86

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