A Pilot Trial of Rituxan in Refractory Myasthenia Gravis
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|ClinicalTrials.gov Identifier: NCT00619671|
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : January 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory Myasthenia Gravis||Drug: Rituximab (Rituxan)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1-2 Pilot Study of Rituximab (Rituxan) in Refractory Myasthenia Gravis.|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
- Drug: Rituximab (Rituxan)
Four weekly IV infusions of Rituxan with dosage individually calculated per subject.Other Names:
- To examine the effects of rituximab on disease activity in MG patients with refractory disease. [ Time Frame: Patients will be followed for one year ]
- To determine the safety and tolerability of rituximab in MG patients with refractory disease. [ Time Frame: Patients will be followed for one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619671
|United States, New York|
|State University of New York|
|Syracuse, New York, United States, 13210|
|United States, Vermont|
|University of Vermont Department of Neurology|
|Burlington, Vermont, United States, 05405|
|Principal Investigator:||Rup Tandan, MD, FRCP||University of Vermont Department of Neurology|