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

NCT00006072 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Rituxan

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    lead NIH

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006072 on ClinicalTrials.gov