drugset / Trial / NCT00259974
RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Phase 3
Completed
60 enrolled
Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitie-Salpetriere · collabHenri Mondor University Hospital · collabHospices Civils de Lyon · collabUniversity Hospital, Basel, Switzerland · collabUniversity Hospital, Bordeaux · collabUniversity Hospital, Limoges · collabUniversity Hospital, Marseille · collab
RandomizedSingle-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-04
- Primary completion
- 2010-01
- Completion
- 2010-01
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |