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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00259974
First received: November 29, 2005
Last updated: May 5, 2011
Last verified: March 2007
History of Changes
  Purpose

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 Intervention Phase
Polyneuropathy
 Drug: Rituximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • INCAT sensory score at 1 year [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    INCAT sensory score at 1 year


Secondary Outcome Measures:
  • Functional scales, MRC score [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Functional scales, MRC score

  • Quality of life (SF 36) [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Quality of life (SF 36)

  • Serum lymphocytes count, IgM level, anti-MAG antibody titers [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Serum lymphocytes count, IgM level, anti-MAG antibody titers

  • Electrophysiological parameters [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Electrophysiological parameters


Enrollment: 60
Study Start Date: April 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rituximab
 Drug: Rituximab
Rituximab
Other Name: Rituximab

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.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259974

Locations
France
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
Investigators
Principal Investigator: Jean-Marc LEGER, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00259974     History of Changes
Other Study ID Numbers: P040409
Study First Received: November 29, 2005
Last Updated: May 5, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Monoclonal Gammopathy of Undetermined Significance
Paraproteinemias
Polyneuropathies
Hypergammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013