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
Genentech, Inc.
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
First received: July 25, 2000
Last updated: June 23, 2005
Last verified: July 2000
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 Intervention Phase
Peripheral Neuropathy
Drug: Rituxan
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Center for Research Resources (NCRR):


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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  More Information

ClinicalTrials.gov Identifier: NCT00006072     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0690  M01RR000036 
Study First Received: July 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 27, 2016