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A Study of Rituxan in the Treatment of Polyneuropathies Associated With Serum IgM Autoantibodies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2000 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006072
First Posted: July 26, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by:
National Center for Research Resources (NCRR)
July 25, 2000
July 26, 2000
December 9, 2005
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No Changes Posted
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A Study of Rituxan in the Treatment of Polyneuropathies Associated With Serum IgM Autoantibodies
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Peripheral neuropathies cause weakness and sensory loss that can produce severe disability. Some neuropathies are immune-mediated and associated with antibodies. It has been postulated that Rituxan treatment may reduce the level of antibody production limiting the loss of muscle strength and hence improve activities of daily living. The purpose of this open-label study (all participants get Rituxan and not placebo) is to determine the safety and effectiveness of Rituxan in the treatment of polyneuropathies associated with serum IgM autoantibodies in those who have already been treated with one course of Rituxan. Subjects will be treated on the in-patient Clinical Research Center with Rituxan for two treatments one week a part and then individual treatments every 10 weeks for one year. The effectiveness of Rituxan will be followed by looking for increases in muscle strength and decreases in the serum IgM autoantibodies.
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Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Peripheral Neuropathy
Drug: Rituxan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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Inclusion Criteria:

  • Diagnosis of characteristic peripheral neuropathy by appropriate history, physical examination, nerve conduction findings and serum autoantibodies.
  • Serum anti-GM1 on anti-MAG antibodies present at high titers in serum, continued by testing in the neuromuscular clinical laboratory at Washington University.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00006072
NCRR-M01RR00036-0690
M01RR000036 ( U.S. NIH Grant/Contract )
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National Center for Research Resources (NCRR)
Genentech, Inc.
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National Center for Research Resources (NCRR)
July 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP