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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

Clinical Trial Details

Multiple Sclerosis (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 fibers in the central nervous system. The nerve fibers 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 fibers. 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.

We want to confirm whether subjects 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.

The purpose of this research trial is to answer the following questions:
• How well does ocrelizumab stabilize, or potentially improve the signs and symptoms of your MS?
• How safe is treatment with ocrelizumab and how well do you tolerate ocrelizumab?
• How does ocrelizumab affect your body, and how well does your body break down ocrelizumab?
• How well does ocrelizumab work compared with standard treatment for MS, such as Rebif®?
• Is there any way we can predict, with outcome of laboratory and brain Magnetic Resonance Imaging (MRI) scans, how ocrelizumab will help in the clinical course of your disease?
As part of this study, we are also asking your permission to let us take blood samples during the study to test protein biomarkers. Biomarkers are substances in the body that can be used as a sign of a specific disease, condition or method to predict how you respond to or tolerate treatment with ocrelizumab. We may use these samples to:
• Learn more how ocrelizumab works
• Learn more how MS can affect your body
• Find new tests that could be used in management of MS and set up standards for these tests

These samples will go to F. Hoffmann-La Roche where they may be destroyed once analysis is done or stored up to 5 years, or per local regulations.

Key Eligibility: 

Inclusion Criteria:

  • Aged ≥18 years old
  • Diagnosis of multiple sclerosis
  • At least 2 documented clinical attacks within last 2 years

Exclusion Criteria:

  • Unable to have serial MRIs
  • Pregnant or breastfeeding
  • Diagnosis of primary progressive MS
  • Disease duration of more than 10 years

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Blagovest Nikolov
bln2001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1110012007

ClinicalTrials.gov:

NCT01247324

Status

Not Yet Recruiting

Age Group

Adult

Sponsor