A Pilot Trial of Rituxan in Refractory Myasthenia Gravis
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
Myasthenia gravis is a disease that happens because the immune system attacks the nervous
system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage
a special part of the muscle that helps transmit impulses from nerves to muscles to allow
muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants
are being asked to participate in this research study because their myasthenia gravis has
either failed to respond to treatments commonly used in the disease, or they have had bad
side-effects from such treatments.
This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a
mouse antibody that has been changed to make it similar to a human antibody. Antibodies are
proteins that can protect the body from foreign invaders, such as bacteria and viruses, by
binding to substances called antigens. Rituxan works by binding to a protein, called the CD20
protein. Rituxan helps to destroy white blood cells that produce antibodies in the body,
called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a
period of approximately 4-6 hours. It has been approved by the Food and Drug Administration
(FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's
Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis.
Treatment with Rituximab is being tried in this research study because Rituximab decreases B
lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic
and otherwise difficult to treat myasthenia gravis.