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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2000 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006072
First received: July 25, 2000
Last updated: June 23, 2005
Last verified: July 2000

July 25, 2000
June 23, 2005
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Complete list of historical versions of study NCT00006072 on ClinicalTrials.gov Archive Site
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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: 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.
 
Active, not recruiting
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00006072
NCRR-M01RR00036-0690, M01RR00036
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National Center for Research Resources (NCRR)
Genentech
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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