UPDATED MAY 2022: THIS STUDY IS FULLY ENROLLED AND NO LONGER RECRUITING PARTICIPANTS.
SUMMARY: Investigators are recruiting 150 Black Americans and Hispanic/Latinx with relapsing MS to determine the effectiveness of
Ocrevus® (ocrelizumab) in these groups. The study, sponsored by Genentech, Inc., also is known as the CHIMES study.
DETAILS:
Rationale: MS affects Black Americans and Hispanic/Latinx in different ways compared with other ethnic groups. Symptoms may differ, the disease may progress faster, and treatments may have different effects. Yet Black Americans and Hispanic/Latinx are less likely to have participated in the clinical trials that tested safety and benefits of approved therapies, , making it difficult to identify the best treatments to help them. This study is exploring the effectiveness of Ocrelizumab in Black Americans and Hispanic/Latinx with relapsing MS. Ocrelizumab targets a specific type of white blood cell – B cells -- which contribute to nerve damage in MS. This therapy is already FDA-approved to treat people with relapsing MS and primary progressive MS.
Eligibility and Details: Participants should be self-identified as Black or Hispanic/Latinx men or women, from ages 18 to 65, who have been diagnosed with a relapsing form of MS (which includes
relapsing-remitting disease and active
secondary progressive disease with relapses). Further eligibility criteria apply.
All participants will receive a first dose of ocrelizumab via infusion into a vein (intravenous). The first dose will be given as two separate infusions, 14 days apart. The following doses will be given as a single infusion every 24 weeks for up to a total of 2 years. Participants will be followed for one year.
The primary outcome of the study is to determine whether treatment affects the proportion of participants who experience a relapse, disability progression, or disease activity on MRI scans. Other outcomes include determining whether treatment affects the time until these events occur, or whether it affects the annual rate of relapses.
Some participants may qualify and can choose to participate in a sub-study that will involve two more years of ocrelizumab treatment and two spinal taps.
What Else is Involved? The study involves up to 10 in-person visits to the study site. Visits will involve 5 MRI scans, up to 9 blood draws, clinical exams, and responding to 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 these studies, and to find out if you are eligible to participate, please call 888-662-6728 (Monday - Friday, 5am - 5pm PT) .
In the U.S., sites are enrolling in the following cities:
Phoenix, Arizona
Scottsdale, Arizona
Los Angeles, California
Washington, District of Columbia
Jacksonville Beach, Florida
Miami, Florida
Atlanta, Georgia
Chicago, Illinois
Indianapolis, Indiana
Baltimore, Maryland
Detroit, Michigan
Saint Louis, Missouri
Hackensack, New Jersey
New York, New York
Syracuse, New York
Greensboro, North Carolina
Dayton, Ohio
Portland, Oregon
Philadelphia, Pennsylvania
Cordova, Tennessee
Nashville, Tennessee
Dallas, Texas
Norfolk, Virginia
Seattle, Washington
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 trademark of Genentech, Inc.