Trial Information
Summary: A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon beta 1-a and Glatiramer Acetate to Either Agent Alone in Patients with Relapsing-Remitting Multiple Sclerosis (CombiRx Phase III)
A multi-center, National Institutes of Health-National Institute
of Neurological Disorders and Stroke (NIH-NINDS) supported clinical
trial examining the combined use of Interferon beta 1-a weekly and
Glatiramer Acetate daily as initial treatment for patients with
relapsing remitting multiple sclerosis. The purpose of the study is
to determine if the combined use of these agents will help reduce
relapse rate when compared to either agent alone. The study is
being conducted at approximately 85 sites across the US and Canada.
Eligible patients will be required to visit their local clinic
every three months over a three year period (15 scheduled visits).
All study-related visits and investigational drug therapies are
provided at no cost. To find a participating study center or site
in your area or for more information, please call
1-866-848-3088.
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
Men and women between 18 and 60 years of age whom:
- Have been diagnosed with relapsing-remitting MS
- Are not pregnant, breast-feeding or planning to become
pregnant
- Are willing and able to give informed consent to participate
- Previous treatement with Interferon beta 1-a (Avonex) or
Glatiramer Acetate (Copaxone)
- Participation in another experimental clinical trial
- History of any signficant heart, liver, lung or kidney disease or
immune deficiency
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Contact:
Heidi D Sadowsky, Clinical Research Coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Telephone: 212-241-2980
Fax: 212-241-9771
Email:
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Trial listings updated: June 1, 2008 at 5:45:52 AM