Abstract

This study is an extension of the original placebo-controlled trial to determine the safety and efficacy of copolymer 1 in patients with relapsing-remitting multiple sclerosis. The controlled phase 3 trial showed that treatment with copolymer 1 was effective in reducing the clinical relapses and in slowing accumulated neurological disability compared to placebo treated patients. Most patients completing the phase 3 placebo controlled study elected to enroll in this open-labeled extension study of copolymer 1 for determination of long term safety and apparent persistence of efficacy. The study will be extended until April, 2000 with the evaluation of all enrolled patients with annual quantitative magnetic resonance imaging, with centralized image analysis conducted a the University of Texas-Houston Health Science Center.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR002558-15
Application #
6309275
Study Section
Project Start
1999-12-01
Project End
2001-02-28
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
15
Fiscal Year
2000
Total Cost
$15,114
Indirect Cost

  Institution

Name
University of Texas Health Science Center Houston
Department
Type
DUNS #
City
Houston
State
TX
Country
United States
Zip Code
77225

  Publications

Chappell, Cynthia L; Darkoh, Charles; Shimmin, Lawrence et al. (2016) Fecal Indole as a Biomarker of Susceptibility to Cryptosporidium Infection. Infect Immun 84:2299-306
Liao, George P; Harting, Matthew T; Hetz, Robert A et al. (2015) Autologous bone marrow mononuclear cells reduce therapeutic intensity for severe traumatic brain injury in children. Pediatr Crit Care Med 16:245-55
Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin Jr, Gerald et al. (2015) Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort. Clin Rheumatol 34:1217-23
Chappell, Cynthia L; Okhuysen, Pablo C; Langer-Curry, Rebecca C et al. (2015) Cryptosporidium muris: infectivity and illness in healthy adult volunteers. Am J Trop Med Hyg 92:50-5
Reveille, John D (2014) An update on the contribution of the MHC to AS susceptibility. Clin Rheumatol 33:749-57
Bethi, Siddharth; Dasgupta, Abhijit; Weisman, Michael H et al. (2013) Functional limitations due to axial and peripheral joint impairments in patients with ankylosing spondylitis: are focused measures more informative? Arthritis Care Res (Hoboken) 65:607-14
Ward, Michael M; Learch, Thomas J; Gensler, Lianne S et al. (2013) Regional radiographic damage and functional limitations in patients with ankylosing spondylitis: differences in early and late disease. Arthritis Care Res (Hoboken) 65:257-65
Benjamin-Garner, Ruby; Stotts, Angela (2013) Impact of smoking exposure change on infant birth weight among a cohort of women in a prenatal smoking cessation study. Nicotine Tob Res 15:685-92
Ornstein, Tisha J; Max, Jeffrey E; Schachar, Russell et al. (2013) Response inhibition in children with and without ADHD after traumatic brain injury. J Neuropsychol 7:1-11
Murthy, Vijaya; Willis, Rohan; Romay-Penabad, Zurina et al. (2013) Value of isolated IgA anti-?2 -glycoprotein I positivity in the diagnosis of the antiphospholipid syndrome. Arthritis Rheum 65:3186-93

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