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

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, March 2007

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
University Hospital, Lyon, France
University Hospital, Basel, Switzerland
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00259974
  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 Associated With Anti-MAG IgM Gammopathy
Drug: Rituximab
Phase III

Genetics Home Reference related topics:   aceruloplasminemia   

ChemIDplus related topics:   Rituximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   Double-Blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

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

Primary Outcome Measures:
  • INCAT sensory score at 1 year

Secondary Outcome Measures:
  • Functional scales, MRC score
  • Quality of life (SF 36)
  • Serum lymphocytes count, IgM level, anti-MAG antibody titers
  • Electrophysiological parameters

Estimated Enrollment:   60
Study Start Date:   April 2006
Estimated Study Completion Date:   January 2009

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

Contacts
Contact: Jean-Marc LEGER, MD     +33(0)-1 42 16 37 73     jean-marc.leger@psl.aphp.fr    

Locations
France
Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski     Recruiting
      PARIS, France, 75015
      Contact: Jean-Marc LEGER, MD,PhD     +33(0)-1 42 16 37 73     jean-marc.leger@psl.aphp.fr    
      Principal Investigator: Jean-Marc LEGER, MD            

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
University Hospital, Lyon, France
University Hospital, Basel, Switzerland

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


Publications:

Study ID Numbers:   P040409, AOM04058
First Received:   November 29, 2005
Last Updated:   March 13, 2007
ClinicalTrials.gov Identifier:   NCT00259974
Health Authority:   France: Ministry of Health

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

Study placed in the following topic categories:
Immunoproliferative Disorders
Neuromuscular Diseases
Rituximab
Hematologic Diseases
Blood Protein Disorders
Peripheral Nervous System Diseases
Polyneuropathies
Paraproteinemias
Monoclonal gammopathy of undetermined significance

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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