Secondary Progressive MS studies underway at NIH

Summary: 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.

Rationale: 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”).