RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
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.
|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|
- INCAT sensory score at 1 year [ Time Frame: during de study ] [ Designated as safety issue: Yes ]INCAT sensory score at 1 year
- 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
|Study Start Date:||April 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Other Name: Rituximab
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.
|Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski|
|Paris, France, 75015|
|Principal Investigator:||Jean-Marc LEGER, MD||Assistance Publique - Hôpitaux de Paris|