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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Trial listings updated: June 1, 2008 at 6:43:33 AM