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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Collaborators: |
Groupe Hospitalier Pitie-Salpetriere University Hospital, Bordeaux University Hospital, Limoges Henri Mondor University Hospital University Hospital, Marseille University Hospital, Lyon, France University Hospital, Basel, Switzerland |
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00259974 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polyneuropathy |
Drug: Rituximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy |
| Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Rituximab
|
Drug: Rituximab
Rituximab
Other Name: Rituximab
|
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 evaluation must be led over one one year period. Acting of a sensitive polyneuropathy and the awaited benefit being the IMPROVEMENT OF the CLINICAL SIGNS, the principal criterion is a sensitive score in addition validated in chronic sensitive polyneuropathies immunodeficiency syndrome.
The patients answering the criteria of inclusion and none inclusion (see V-2) will be randomized in 2 groups: the first group will receive a perfusion IV of rituximab to the amount of 375 mg/m2 of body surface, once per week, during 4 weeks (see VII-3); the second group will receive 4 perfusions IV of placebo according to same methods'. The evaluation (see VI-1) will be carried out at the time of the randomization, then repeated in 3 months, 6 months, 9 months and 1 year.
Eligibility| Ages Eligible for Study: | 18 Years to 82 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski | |
| Paris, France, 75015 | |
| Principal Investigator: | Jean-Marc LEGER, MD | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Isabelle BRINDEL, Department of Clinical Research of developpement |
| ClinicalTrials.gov Identifier: | NCT00259974 History of Changes |
| Other Study ID Numbers: | P040409 |
| Study First Received: | November 29, 2005 |
| Last Updated: | May 5, 2011 |
| Health Authority: | France: Ministry of Health |
|
Anti-MAG monoclonal gammopathy Polyneuropathy Rituximab |
|
Monoclonal Gammopathy of Undetermined Significance Paraproteinemias Polyneuropathies Hypergammaglobulinemia Blood Protein Disorders Hematologic Diseases Immunoproliferative Disorders Immune System Diseases Peripheral Nervous System Diseases |
Neuromuscular Diseases Nervous System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
