Status:
COMPLETED
RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Bordeaux
Conditions:
Polyneuropathy
Eligibility:
All Genders
18-82 years
Phase:
PHASE3
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 l...
Detailed Description
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...
Eligibility Criteria
Inclusion
- IgM monoclonal gammopathy
- Anti-MAG antibody titers \> 1.1000 BTU (ELISA)
- Worsening polyneuropathy with INCAT score \> 4
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00259974
Start Date
April 1 2006
End Date
January 1 2010
Last Update
May 6 2011
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski
Paris, France, 75015