CompletedPhase 3

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

France60 participantsStarted 2006-04

Plain-language 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.

Who can participate

Age range18 Years – 82 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

INCAT sensory score at 1 year

Timeframe: during de study

Trial details

NCT IDNCT00259974

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Polyneuropathy trials