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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT00259974
Phase
PHASE3
Status
Completed

Conditions

  • Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 82 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 30, 2006
Status verified
Mar 2007
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Rituximab

Primary Outcome Measure

INCAT sensory score at 1 year [ Time Frame: during de study ]

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