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
Posted Date: Sep 9, 2017
- Investigator: Joseph Nicolas
- Specialties: Multiple Sclerosis, Neurology
- Type of Study: Drug
This study is being conducted by F. Hoffmann-La Roche Ltd. (Roche) and Genentech Inc, called “Sponsor” later on in this document. We want to confirm whether patients treated with ocrelizumab may experience even fewer clinical relapses (also called clinical attacks or exacerbations) compared with those treated with Rebif®, a currently approved drug for MS. MS is believed to be a disease where the body’s immune system attacks and damages myelin. This is the fatty substance that surrounds and protects the nerve fibres in the central nervous system. The nerve fibres themselves can also be damaged. Scar tissue (sclerosis) results due to the damaged myelin. As a result, nerve impulses travelling to and from the brain and spinal cord are distorted or interrupted, producing the variety of symptoms that can occur. During relapses your own immune system causes an inflammation of some nerve fibres. This is a time when your symptoms rapidly get worse. Treatments that reduce such type of 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 cells (B-cells). These are involved in the process of inflammation which is believed to play a role in some of the symptoms of MS. It is similar to a drug called rituximab which is already approved for use as a treatment of Non-Hodgkin's Lymphoma (type of blood cancer) and Rheumatoid Arthritis (autoimmune joint disease). Ocrelizumab has a slightly different structure to rituximab and it is thought that this may lessen certain side effects.
• You Must Be 18 To 55 Years Of Age. • You Must Pass The Screening Medical Examinations And Tests (Including A Pregnancy Test For Females Who Are Able To Become Pregnant During The Study); If You Or Your Female Partner (If You Are Male) Are Able To Become Pregnant, You Must Agree To Use 2 Methods Of Effective Contraception During The Study Treatment And Safety Follow Up. • You Must Not Have A History Of Medical Problems That Could Interfere With Your Safety During The Study, Or With Study Results. • You Must Be Willing To Adhere To The Study Requirements And Restrictions. There Are Also Other Requirements For Taking Part In This Study. Your Study Doctor Will Review These With You. In Exceptional Circumstances, Even If You Have Given Your Consent, You May Not Participate In The Trial (E.G., Ocrelizumab Is No Longer Available, Other Unforeseen Situations). You Will Still Receive Care For Your Disease And Will Not Lose Any Benefits To Which You Would Otherwise Be Entitled. There Might Also Be Other Requirements For Taking Part In The Open-Label Extension Phase Of The Study. Your Study Doctor Will Review These With You.
Relapsing-Remitting, Opera, Ocrelizumab, Multiple Sclerosis, Null
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