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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT00259974
• Collaborator: Groupe Hospitalier Pitie-Salpetriere (Other), University Hospital, Bordeaux (Other), University Hospital, Limoges (Other), Henri Mondor University Hospital (Other), University Hospital, Marseille (Other), Hospices Civils de Lyon (Other), University Hospital, Basel, Switzerland (Other)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 1.3

Study Details

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
• 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: Apr 1, 2006
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Rituximab	Drug: Rituximab; Rituximab

Outcome Measures

Primary Outcome Measures

1. INCAT sensory score at 1 year [during de study]

   INCAT sensory score at 1 year

Secondary Outcome Measures

1. Functional scales, MRC score [during the study]

   Functional scales, MRC score

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

   Quality of life (SF 36)

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

   Serum lymphocytes count, IgM level, anti-MAG antibody titers

4. Electrophysiological parameters [during the study]

   Electrophysiological parameters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 82 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• ClinicalTrials.gov Identifier: NCT00259974
• Other Study ID Numbers: P040409
• First Posted: Dec 1, 2005
• Last Update Posted: May 6, 2011
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: Anti-MAG monoclonal gammopathy; Polyneuropathy; Rituximab
• Additional relevant MeSH terms: Polyneuropathies; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance; Rituximab

Study Results

No Results Posted as of May 6, 2011