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

Drug Information available for: 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:

Leger JM. A review of the medical management of chronic inflammatory demyelinating polyradiculoneuropathy. Expert Opin Pharmacother. 2005 Apr;6(4):569-82.

Study ID Numbers:	P040409, AOM04058
Study 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
Monoclonal Gammopathies, Benign
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
Hypergammaglobulinemia
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009