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Multiple Sclerosis
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OPERA

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

This study will evaluate whether or not individuals diagnosed with a relapsing form of multiple sclerosis (MS) treated with an investigational drug called ocrelizumab (o-cree-liz-u-mab) experience fewer clinical relapses (recurrences) compared to those treated with Rebif® (interferon beta 1a), an approved drug for MS. Ocrelizumab is an experimental drug, which means that it is still being tested and is not yet approved by the US Food and Drug Administration (FDA). This study will also evaluate the safety of ocrelizumab compared to that of Rebif®.

MS is an autoimmune disease where the body’s immune system attacks and damages myelin. This is the substance that surrounds and protects the nerve fibers in the central nervous system. The nerve fibers themselves can also be damaged. Scar tissue (sclerosis) results from damaged myelin. As a result, nerve impulses travelling to and from the brain and spinal cord are distorted or interrupted, producing a variety of symptoms. During relapses your own immune system causes inflammation of some nerve fibers. This is when your symptoms rapidly get worse.

Treatments that reduce inflammation can be effective in stabilizing or improving your MS symptoms and reducing the number of relapses. Ocrelizumab temporarily removes a type of white blood cell (B-cells). These are involved in the process of inflammation that is believed to play a role in some of the symptoms of MS.

Participants will have a 50% chance (like tossing a coin) of receiving either ocrelizumab or Rebif®. In addition, because this study is double blinded, participants will also be “treated” with a placebo medication. A placebo medication is one that contains no active substance but may resemble a real medication. Since ocrelizaumab is administered by infusion, and Rebif®. is administered by self-injection, patients enrolled in this study will be required to receive both types of delivery (infusion and injection) so that no one will be able to tell which active medication the patient is truly being given.

This study will last for approximately two years.

Closed to enrollment.