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Merck Serono Completes Enrollment in the REFLEX Trial of Rebif(R) in Patients at Risk of Developing Multiple Sclerosis
Date:9/16/2008

GENEVA, Sept. 17 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that patient enrollment has been completed in the REFLEX trial (Rebif FLEXible dosing in early multiple sclerosis). This randomized, double-blind, placebo-controlled, international Phase III trial is designed to evaluate the therapeutic benefit of Rebif(R) (interferon beta-1a) on the time to conversion to multiple sclerosis (MS) in people with a first clinical event suggestive of the disease.

"It has been demonstrated that treatment with interferon beta can reduce the risk of developing multiple sclerosis," said Anton Hoos, Executive Vice President, Global Development, Merck Serono. "However, additional research still needs to be conducted in this area and we believe the REFLEX study will provide valuable insights."

A total of 517 patients considered at risk of developing MS due to a recently experienced isolated demyelinating event (e.g. optic neuritis, myelopathy or brainstem syndrome) and having magnetic resonance imaging (MRI) brain scans consistent with early signs of MS have been enrolled in the REFLEX trial. Study participants were randomized in a 1:1:1 ratio to receive either Rebif(R) 44 micrograms three times a week, Rebif(R) 44 micrograms once a week, or placebo as a subcutaneous injection. Patients will be treated for a period of 24 months, or up to the time when they experience a second attack leading to a diagnosis of clinically definite MS. At this point, patients are offered open-label treatment with Rebif(R) 44 micrograms three times a week.

The primary endpoint of the REFLEX trial is time to conversion to MS, according to the McDonald criteria. Further endpoints include time to conversion to clinically definite MS (the main secondary endpoint), assessments of MRI brain scans, clinical relapses and disability progression.

Rebif(R) is currently approved for the treatment of relapsing forms of MS. It has been p
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SOURCE Merck Serono International S A
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