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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.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
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

MedlinePlus related topics:   Peripheral Nerve Disorders   

Drug Information available for:   Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
  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


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

Study placed in the following topic categories:
Autoantibodies
Neuromuscular Diseases
Rituximab
Peripheral Nervous System Diseases
Polyneuropathies

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

ClinicalTrials.gov processed this record on December 03, 2008




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