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Rituximab Versus Placebo in People With Secondary Progressive Multiple Sclerosis



See All Multiple Sclerosis Trials

The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

This study evaluates the safety and effectiveness of using the drug rituximab both intravenously and via an intrathecal injection to treat secondary progressive multiple sclerosis (SP-MS). MS is an inflammatory disorder of the central nervous system that progressively weakens and destroys the pathways of the nervous system. SP-MS is the chronic phase of MS. Most people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS.

Researchers are interested in determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to target certain white blood cells that are thought to play a role in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord, participants will receive it by intravenous drip and by intrathecal injection (through a lumbar puncture into the cerebrospinal fluid).

The study will last 3 years and will be divided into two parts: a 1-year pre-treatment baseline and a 2 year treatment period during which there will be a total of 4 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 of brain and nervous system function. There will be approximately 7 outpatient clinic visits. Outpatient clinic visits will last 2-5 hours. The 4 infusion visits will each require a 2-3 day admission to the NIH Clinical Center.

Phase: 

Phase 1/2

Eligibility Criteria:

Please follow this link for trial eligibility information to share with your doctor.

Study Design: 

Interventional, Purpose:  Treatment

Study Locations: 

Bethesda, Maryland

For more information:

Contact: Jamie Cherup, CRNP or Jenn Dwyer, RN Tel: 301-496-0586 or email: nibclinicalgroup@ninds.nih.gov
Visit: http://clinicaltrials.gov/ct2/show/NCT01212094

Last Reviewed May 1, 2014