Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259974
Status:
COMPLETED
Last Update Posted:
2011-05-06
First Post:
2005-11-29
Brief Title:
RIMAG Study Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nervesRituximab 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 mgm2 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
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 mgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None