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

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ClinicalTrials.gov Identifier: NCT00259974
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : May 6, 2011
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Polyneuropathy Drug: Rituximab Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Study Start Date : April 2006
Primary Completion Date : January 2010
Study Completion Date : January 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Drug: Rituximab

Outcome Measures

Primary Outcome Measures :
  1. INCAT sensory score at 1 year [ Time Frame: during de study ]
    INCAT sensory score at 1 year

Secondary Outcome Measures :
  1. Functional scales, MRC score [ Time Frame: during the study ]
    Functional scales, MRC score

  2. Quality of life (SF 36) [ Time Frame: during the study ]
    Quality of life (SF 36)

  3. Serum lymphocytes count, IgM level, anti-MAG antibody titers [ Time Frame: during the study ]
    Serum lymphocytes count, IgM level, anti-MAG antibody titers

  4. Electrophysiological parameters [ Time Frame: during the study ]
    Electrophysiological parameters

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259974

Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Bordeaux
University Hospital, Limoges
Henri Mondor University Hospital
University Hospital, Marseille
Hospices Civils de Lyon
University Hospital, Basel, Switzerland
Principal Investigator: Jean-Marc LEGER, MD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00259974     History of Changes
Other Study ID Numbers: P040409
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Anti-MAG monoclonal gammopathy

Additional relevant MeSH terms:
Monoclonal Gammopathy of Undetermined Significance
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents