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Trial Information
Summary: Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis
Inclusion Criteria:
- relapsing form of MS
- screening EDSS score below 6.0
- at least one clinical relapse in the 12 months before screening
- active disease, defined by set of MRI activity criteria
- failed prior treatment with beta-interferons
Exclusion Criteria:
- signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis
- known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
- pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
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Contact:
Mary Faulkner, Study Coordinator
Department of Neurology University of Kentucky College of Medicine
Kentucky Clinic, Room L-445
740 S. Limestone Street
Lexington, KY 40536-0284
Telephone: 859-218-5006
Fax: 859 323-5943
Email:
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Trial listings updated: June 1, 2008 at 6:43:33 AM
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