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MS Trial Alert: Investigators Recruiting for Trial Comparing Ocrevus® to Placebo for Slowing the Progression of Upper Limb Disability in People with Primary Progressive MS

August 16, 2021

SUMMARY: Investigators in the U.S. and abroad are recruiting 1000 people with primary progressive MS for a study comparing ocrelizumab (Ocrevus®) to placebo for slowing the progression of upper limb disability. The study – also called O’HAND – is sponsored by F. Hoffmann-La Roche.
 
DETAILS
Rationale: Ocrevus is approved for the treatment of primary progressive MS or relapsing MS, based on clinical trials showing significant benefits against MS relapses and progression. This study is specifically testing whether ocrelizumab can help to preserve arm and hand function. Having the use of the upper limbs can make the difference between remaining independent and requiring substantial daily help from others. Ocrelizumab is an investigational product for purposes of this research.
 
Eligibility and Details: Participants should be 18 to 65 years old, and diagnosed with primary progressive MS.
 
Participants will be randomly assigned to receive either ocrelizumab or an inactive placebo via intravenous (into the vein) infusion for 120 weeks. The first two doses are given 14 days apart, and then infusions are given every 24 weeks.
 
The primary outcome of the study will compare whether ocrelizumab may slow the progression of upper limb disability using a test of arm and hand function called the 9-hole peg test. Secondary outcomes include measures of disability progression using the EDSS scale, changes in MRI-detected brain tissue volume, and safety. The study involves visits to the study site every three months, and will involve MRI scans, blood draws, clinical exams, and questionnaires.
 
Please note: This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19.
 
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study listing on clinicaltrials.gov, call 888-662-6728 or email global-roche-genentech-trials@gene.com.

In the U.S., sites are enrolling in the following cities:
Phoenix, Arizona
Arcadia, California
Newport Beach, California
Washington, District of Columbia
Boca Raton, Florida
Clearwater, Florida
Orlando, Florida
Vero Beach, Florida
Northbrook, Illinois
Kansas City, Kansas
Clinton Township, Michigan
Detroit, Michigan
United States, Nebraska
Omaha, Nebraska
Albuquerque, New Mexico
Amherst, New York
Buffalo, New York
Columbus, Ohio
Philadelphia, Pennsylvania
Greer, South Carolina
Nashville, Tennessee
Houston, Texas
Norfolk, Virginia
Milwaukee, Wisconsin
 
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.
 
Ocrevus is a registered trademark of Genentech, Inc., A member of the Roche Group.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. 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. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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