Researchers at the National Institutes of Health in Bethesda, Maryland are looking to recruit 80 people with secondary-progressive Multiple Sclerosis (secondary-progressive MS) to evaluate the safety and effectiveness of rituximab. Rituximab is an experimental drug for treating MS. In this study it will be given intravenously and directly into the cerebrospinal fluid by lumbar puncture (“spinal tap”). The study is funded by the National Institute of Neurological Disorders and Stroke.
MS is an inflammatory disorder that progressively weakens and destroys the pathways of the nervous system. Secondary-progressive MS begins with an initial relapsing-remitting disease course, followed by progression of disability that may include occasional relapses and minor remissions and plateaus. There are currently no effective treatments for people with secondary-progressive MS who do not experience relapses or who do not have “active” lesions on MRI.
Under normal conditions, the blood brain barrier separates the brain and spinal cord from the bloodstream and limits what can gain access to the nervous system. In active stages of MS, the inflammation in the brain and spinal cord leads to breakdown of this barrier. This break-down allows MS medications to reach the brain and spinal cord without being screened out. In people with secondary-progressive MS who do not have “active” disease, the blood-brain barrier is intact.
Drugs that could stop the inflammation simply cannot reach the areas of the brain and spinal cord where they are needed.
Researchers want to understand whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to slow down or stop the progression of secondary-progressive MS. In people with earlier, active disease, this drug can stop inflammation in the brain. However, intravenous rituximab did not help people with primary-progressive MS, possibly because the drug could not get through the intact blood-brain barrier. In this new trial, to ensure that the rituximab will reach the brain and spinal cord in people with secondary-progressive MS, participants will receive it intravenously and by injection through a lumbar puncture into the cerebrospinal fluid (“spinal tap”).
Eligibility & Details:
Participants should be between 18 and 65 years of age and have been diagnosed with secondary-progressive MS and can walk for 25 feet with assistance.
People with other types of MS, or other types of brain or spinal cord disease may not be able to participate. Women who are pregnant, are breast-feeding, or are planning to become pregnant during the course of the study are not eligible.
The study will last 3 years and will be divided into two parts. The first part is a 1-year baseline period during which participants will not be treated. The second part is a 2-year treatment period during which there will be a total of 3 infusions with either rituximab or placebo. Participants will have periodic follow-up clinic visits that will include brain magnetic resonance imaging (MRI) scans, blood tests, and other evaluations. There will be approximately 7 outpatient clinic visits. Outpatient clinic visits will last 2-5 hours. The 3 infusion visits will each require a 2-3 day admission to the NIH Clinical Center.
There is no cost to take part in this study. Reimbursement for travel, lodging, and food will be offered. People in the study will not receive payment.
The primary outcome measure is to determine whether rituximab can decrease brain atrophy – loss of brain tissue volume – significantly more than placebo.
To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Joan Ohayon
or Rosalind Ebinger
at 301-496-0064 (or TTY: 1-866-411-1010).
Please refer to study number 10-N-0212 or www.ClinicalTrials.gov identifier NCT01212094.
a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).