Polyneuropathy Clinical Trial
Official title:
Double-blind Randomized 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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