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MS Trial Alert: Investigators Recruiting for Study of Ocrelizumab in People with Relapsing-Remitting MS Who Have Not Responded to Other Therapies

December 14, 2016

Summary: Investigators throughout the United States and Canada are recruiting for a study of intravenous ocrelizumab (Genentech, Inc.) in people with relapsing-remitting MS who have not responded to other disease-modifying therapies. The study is funded by Genentech, A Member of the Roche Group.
 
Rationale: Ocrelizumab is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and reduces the numbers of certain B cells that are circulating in the blood. B cells have several functions including making antibodies, and they are believed to play a role in immune-system-mediated damage to brain and spinal cord tissues in MS. Based on the results of phase III studies, Genentech is pursuing marketing approval of ocrelizumab for both primary-progressive MS and relapsing multiple sclerosis.
 
Eligibility and Details: Participants in this study should be ages 18 to 55, with a diagnosis of relapsing-remitting MS. Participants have been treated with two or fewer disease-modifying therapies, each for six months or more. The most recent therapy was discontinued due to lack of effectiveness. More details on the enrollment criteria are available from the contact below.
 
Participants will receive ocrelizumab via two intravenous infusions of 300 mg separated by 14 days, followed by a single infusion of 600 mg every 24 weeks for a maximum of 96 weeks (four doses).
 
The primary outcome being measured is the percentage of participants who do not experience any of the following events over 96 weeks: relapse, new disease activity on MRI, or disability progression as measured by a clinical scale. Secondary outcomes include the same endpoint as the primary, measured at 24 and 48 weeks, and how long it takes until one such event (i.e., either a relapse, or disability progression, or MRI activity) is experienced.
 
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please call 1-888-662-6728, or email global.rochegenentechtrials@roche.com. Please use Reference Study ID Number: MN30035.
Sites will be enrolling in the following cities:
Cullman, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona
Tucson, Arizona
Carlsbad, California
Carmichael, California
Fullerton, California
La Jolla, California
San Francisco, California
Torrance, California
Centennial, Colorado
Englewood, Colorado
Fort Collins, Colorado
Fairfield, Connecticut
Maitland, Florida
Miami, Florida
Sunrise, Florida
Tampa, Florida
Atlanta, Georgia
Chicago, Illinois
Northbrook, Illinois
Avon, Indiana
Indianapolis, Indiana
Kansas City, Kansas
Lexington, Kentucky
Louisville, Kentucky
New Orleans, Louisiana
Baltimore, Maryland
Boston, Massachusetts
Worcester, Massachusetts
 
Detroit, Michigan
Edina, Minnesota
St. Louis, Missouri
Freehold, New Jersey
Newark, New Jersey
Teaneck, New Jersey
Buffalo, New York
Latham, New York
Mineola, New York
New York, New York
Patchogue, New York
Stony Brook, New York
Raleigh, North Carolina
Akron, Ohio
Cincinnati, Ohio
Cleveland, Ohio
Columbus, Ohio
Oklahoma City, Oklahoma
Portland, Oregon
Pittsburgh, Pennsylvania
Cordova, Tennessee
Knoxville, Tennessee
Houston, Texas
Lubbock, Texas
Round Rock, Texas
San Antonio, Texas
Salt Lake City, Utah
Richmond, Virginia
Seattle, Washington
Tacoma, Washington
 
 
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF). Without participants in research studies, MS research would come to a standstill. Read more here.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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