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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Groupe Hospitalier Pitie-Salpetriere; Henri Mondor University Hospital; Hospices Civils de Lyon; University Hospital, Basel, Switzerland; University Hospital, Bordeaux; University Hospital, Limoges; University Hospital, Marseille
• Treatments: Rituximab

Criteria

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