Serono begins recruitment in phase 3 multiple sclerosis trial

By Elaine Rigoli

Tampa, Fla., May 4 - Serono SA announced Thursday that recruitment in the United States is beginning for the phase 3 Clarity study of oral cladribine for the treatment of patients with relapsing forms of multiple sclerosis.

This multinational study was successfully initiated outside the United States in 2005 and will now expand to include 17 clinical trial sites in the United States.

The study is one of the largest multiple sclerosis trials ever conducted, and enrollment is on track to be completed in 2006, the company said in a news release.

Clarity, a two-year, double-blind, placebo-controlled phase 3 study of more than 1,200 patients, is designed to assess patients' clinical relapses, disability progression and magnetic resonance imaging brain activity.

Serono said previous clinical trials using cladribine administered by injection in patients with multiple sclerosis showed positive effects in reduction of new lesion development in the brain as seen on magnetic resonance imaging scans; reductions in relapses were also observed.

Serono is an international biotechnology company with corporate headquarters in Geneva.

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