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RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

NCT00259974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-05-06

No results posted yet for this study

Summary

Polyneuropathy associated with anti-MAG monoclonal IgM gammopathy is responsive of mainly a sensory deficit in predominantly males ,aged 40-70 years. Significantly high serum anti-MAG antibodies are linked with demyelinating features of the peripheral nerves.Rituximab, an anti-CD 20 monoclonal antibody is a new drug which reduces B-lymphocytes. This study will test the safety and efficacy of rituximab in the treatment of patients with anti-MAG polyneuropathy.

Conditions

  • Polyneuropathy

Interventions

DRUG

Rituximab

Rituximab

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER

  • University Hospital, Bordeaux

    collaborator OTHER

  • University Hospital, Limoges

    collaborator OTHER

  • Henri Mondor University Hospital

    collaborator OTHER

  • University Hospital, Marseille

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Marc LEGER, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT00259974 on ClinicalTrials.gov