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

Phase 3

Completed

• Conditions: Polyneuropathy
• Interventions: Drug: Rituximab

• Registration Number: NCT00259974
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study First Posted: 2005-12-01
• Study Start: 2006-04
• Status Verified: 2007-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Rituximab	Rituximab

Primary Outcome Measures

Name	Time	Method
INCAT sensory score at 1 year	during de study	INCAT sensory score at 1 year

Secondary Outcome Measures

Name	Time	Method
Functional scales, MRC score	during the study	Functional scales, MRC score
Quality of life (SF 36)	during the study	Quality of life (SF 36)
Serum lymphocytes count, IgM level, anti-MAG antibody titers	during the study	Serum lymphocytes count, IgM level, anti-MAG antibody titers
Electrophysiological parameters	during the study	Electrophysiological parameters

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski; 🇫🇷 Paris, France