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A Study of Rituxan in the Treatment of Polyneuropathies Associated With Serum IgM Autoantibodies
This study is ongoing, but not recruiting participants.
First Received: July 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsor: National Center for Research Resources (NCRR)
Collaborator: Genentech
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00006072
  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 Intervention Phase
Peripheral Neuropathy
Drug: Rituxan
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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

Additional relevant MeSH terms:
Immunologic Factors
Neuromuscular Diseases
Antineoplastic Agents
Rituximab
Therapeutic Uses
Peripheral Nervous System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009