Investigators are recruiting 88 people with relapsing MS and 16 people with primary progressive MS for a study to explore the mechanism of action of ocrelizumab and how it affects immune cells. During the study, participants will undergo two lumbar punctures, also known as “spinal taps.”
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.
Ocrelizumab is available to people with primary progressive MS who meet specific criteria through an expanded access program. Read more
Eligibility and Details:
Participants are aged 18 to 55 and diagnosed with relapsing or primary progressive MS. Further details on enrollment criteria are available from the contact below.
Participants will receive three doses of ocrelizumab (by infusion into the vein) over one year, and will be followed for 48 weeks after the last infusion of ocrelizumab. Participants will receive a lumbar puncture (also known as a spinal tap, read more here
) before treatment and afterward.
The primary objective is to understand the impact of ocrelizumab treatment on a biomarker of nerve cell damage that is found in spinal fluid, and to assess the number of specific B and T cells in the spinal fluid before and after treatment.
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 firstname.lastname@example.org
. Please use Reference Study ID Number: ML29966.
Sites will be enrolling in the following U.S. cities:
Palo Alto, California
San Francisco, California
New Haven, Connecticut
Saint Louis, Missouri
Latham, New York
Chapel Hill, North Carolina
Oklahoma City, Oklahoma
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