Clinical Trial: RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
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 Summary:
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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: INCAT sensory score at 1 year [ Time Frame: during de study ]
Original Primary Outcome: INCAT sensory score at 1 year
Current Secondary Outcome:
- Functional scales, MRC score [ Time Frame: during the study ]Functional scales, MRC score
- Quality of life (SF 36) [ Time Frame: during the study ]Quality of life (SF 36)
- Serum lymphocytes count, IgM level, anti-MAG antibody titers [ Time Frame: during the study ]Serum lymphocytes count, IgM level, anti-MAG antibody titers
- Electrophysiological parameters [ Time Frame: during the study ]Electrophysiological parameters
Original Secondary Outcome:
- Functional scales, MRC score
- Quality of life (SF 36)
- Serum lymphocytes count, IgM level, anti-MAG antibody titers
- Electrophysioloogical parameters
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 29, 2005
Date Started: April 2006
Date Completion:
Last Updated: May 5, 2011
Last Verified: March 2007