RIMAG Study: Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

Polyneuropathy Clinical Trial

Official title:

Double-blind Randomized Trial of Rituximab Versus Placebo in Polyneuropathy Associated With Anti-MAG IgM Monoclonal Gammopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259974
• Other study ID #: P040409
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2005
• Last updated: May 5, 2011
• Start date: April 2006
• Est. completion date: January 2010

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Paraproteinemias
• Polyneuropathies
• Polyneuropathy

Intervention

Drug:
• Rituximab
Rituximab

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski	Paris

Sponsors (8)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Groupe Hospitalier Pitie-Salpetriere, Henri Mondor University Hospital, Hospices Civils de Lyon, University Hospital, Basel, Switzerland, University Hospital, Bordeaux, University Hospital, Limoges, University Hospital, Marseille

Country where clinical trial is conducted

France, 

References & Publications (1)

Léger JM. A review of the medical management of chronic inflammatory demyelinating polyradiculoneuropathy. Expert Opin Pharmacother. 2005 Apr;6(4):569-82. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INCAT sensory score at 1 year	INCAT sensory score at 1 year	during de study	Yes
Secondary	Functional scales, MRC score	Functional scales, MRC score	during the study	Yes
Secondary	Quality of life (SF 36)	Quality of life (SF 36)	during the study	Yes
Secondary	Serum lymphocytes count, IgM level, anti-MAG antibody titers	Serum lymphocytes count, IgM level, anti-MAG antibody titers	during the study	Yes
Secondary	Electrophysiological parameters	Electrophysiological parameters	during the study	Yes