RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Primary Purpose
Polyneuropathy
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Polyneuropathy focused on measuring Anti-MAG monoclonal gammopathy, Polyneuropathy, Rituximab
Eligibility 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
Sites / Locations
- Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Rituximab
Outcomes
Primary Outcome Measures
INCAT sensory score at 1 year
INCAT sensory score at 1 year
Secondary Outcome Measures
Functional scales, MRC score
Functional scales, MRC score
Quality of life (SF 36)
Quality of life (SF 36)
Serum lymphocytes count, IgM level, anti-MAG antibody titers
Serum lymphocytes count, IgM level, anti-MAG antibody titers
Electrophysiological parameters
Electrophysiological parameters
Full Information
NCT ID
NCT00259974
First Posted
November 29, 2005
Last Updated
May 5, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Groupe Hospitalier Pitie-Salpetriere, University Hospital, Bordeaux, University Hospital, Limoges, Henri Mondor University Hospital, University Hospital, Marseille, Hospices Civils de Lyon, University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00259974
Brief Title
RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Official Title
Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Groupe Hospitalier Pitie-Salpetriere, University Hospital, Bordeaux, University Hospital, Limoges, Henri Mondor University Hospital, University Hospital, Marseille, Hospices Civils de Lyon, University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathy
Keywords
Anti-MAG monoclonal gammopathy, Polyneuropathy, Rituximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rituximab
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab
Primary Outcome Measure Information:
Title
INCAT sensory score at 1 year
Description
INCAT sensory score at 1 year
Time Frame
during de study
Secondary Outcome Measure Information:
Title
Functional scales, MRC score
Description
Functional scales, MRC score
Time Frame
during the study
Title
Quality of life (SF 36)
Description
Quality of life (SF 36)
Time Frame
during the study
Title
Serum lymphocytes count, IgM level, anti-MAG antibody titers
Description
Serum lymphocytes count, IgM level, anti-MAG antibody titers
Time Frame
during the study
Title
Electrophysiological parameters
Description
Electrophysiological parameters
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc LEGER, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15934883
Citation
Leger JM. A review of the medical management of chronic inflammatory demyelinating polyradiculoneuropathy. Expert Opin Pharmacother. 2005 Apr;6(4):569-82. doi: 10.1517/14656566.6.4.569.
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RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
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