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A study of Rituxan in the treatment of polyneuropathies associated with serum IgM autoantibodies - Article


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Hereditary neuropathy with liability to pressure palsies

compression neuropathy; entrapment neuropathy; familial pressure sensitive neuropathy; HNPP; inherited tendency to pressure palsies; tomaculous neuropathy


Clinical Trial: A study of Rituxan in the treatment of polyneuropathies associated with serum IgM autoantibodies

This study is no longer recruiting patients.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Genentech
Information provided by: National Center for Research Resources (NCRR)

Purpose

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 Treatment or Intervention Phase
Peripheral Neuropathy
 Drug: Rituxan
Phase II

MedlinePlus related topics:  Peripheral Nerve Disorders

Study Type: Interventional
Study Design: Treatment, Open Label

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

More Information

Study ID Numbers:  NCRR-M01RR00036-0690; M01RR00036
Record last reviewed:  July 2000
Last Updated:  October 13, 2004
Record first received:  July 25, 2000
ClinicalTrials.gov Identifier:  NCT00006072
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 21, 2008



Page Updated: September 6, 2005
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