April 1, 2009
Summary: Investigators at approximately 30 sites in the United States and others nationwide are studying the safety and tolerability of oral cladribine (EMD Serono Inc.) compared to placebo as an add-on therapy to injectable interferon beta-1a therapy – Rebif® (EMD Serono and Pfizer), Avonex® (Biogen Idec), or Betaseron® (Bayer Healthcare Pharmaceuticals) – in people with active MS. A total of 200 people are expected to enroll in this study. EMD Serono Inc. is sponsoring this study.
Rationale: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine has been used to treat hairy cell leukemia. Studies have suggested a potential benefit in people with certain types of MS. Cladribine has been designated by the FDA as a “Fast Track Product,” which should expedite its future review.
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