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

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ClinicalTrials.gov Identifier: NCT00006072
Recruitment Status : Unknown
Verified July 2000 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : July 26, 2000
Last Update Posted : June 24, 2005
Genentech, Inc.
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: Rituxan Phase 2

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

ClinicalTrials.gov Identifier: NCT00006072     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0690
M01RR000036 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2000

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents