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

May 5, 2011 updated by: Assistance Publique - Hôpitaux de Paris

Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acting of a polyneuropathy for which there is not any treatment of reference today (see supra), a test of double-knowledge versus placebo is justified. Acting of a chronic polyneuropathy, the clinical evaluation must be led over one one year period. Acting of a sensitive polyneuropathy and the awaited benefit being the IMPROVEMENT OF the CLINICAL SIGNS, the principal criterion is a sensitive score in addition validated in chronic sensitive polyneuropathies immunodeficiency syndrome.

The patients answering the criteria of inclusion and none inclusion (see V-2) will be randomized in 2 groups: the first group will receive a perfusion IV of rituximab to the amount of 375 mg/m2 of body surface, once per week, during 4 weeks (see VII-3); the second group will receive 4 perfusions IV of placebo according to same methods'. The evaluation (see VI-1) will be carried out at the time of the randomization, then repeated in 3 months, 6 months, 9 months and 1 year.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IgM monoclonal gammopathy
  • Anti-MAG antibody titers > 1.1000 BTU (ELISA)
  • Worsening polyneuropathy with INCAT score > 4
  • Informed consent

Exclusion Criteria:

  • Severe comorbidity
  • Other concurrent causes of polyneuropathy
  • Concurrent immunosuppressive therapies (wash-out > 3 months)
  • Previous treatment with rituximab
  • Lymphoproliferative disease indicating other immunosuppressive treatment
  • Unability to follow-up
  • Previous documented side-effects with components involved in the tested drug
  • White cell count < 1500/mm3 or platelet count < 75.000/mm3
  • Patient under law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rituximab
Drug: Rituximab
Rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
INCAT sensory score at 1 year
Time Frame: during de study
INCAT sensory score at 1 year
during de study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional scales, MRC score
Time Frame: during the study
Functional scales, MRC score
during the study
Quality of life (SF 36)
Time Frame: during the study
Quality of life (SF 36)
during the study
Serum lymphocytes count, IgM level, anti-MAG antibody titers
Time Frame: during the study
Serum lymphocytes count, IgM level, anti-MAG antibody titers
during the study
Electrophysiological parameters
Time Frame: during the study
Electrophysiological parameters
during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Hospices Civils de Lyon
University Hospital, Basel, Switzerland
University Hospital, Bordeaux
University Hospital, Limoges
Groupe Hospitalier Pitie-Salpetriere
Henri Mondor University Hospital
University Hospital, Marseille

Investigators

  • Principal Investigator: Jean-Marc LEGER, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 29, 2005

First Submitted That Met QC Criteria

November 29, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

May 6, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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