NCT00259974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

May 6, 2011

Status Verified

March 1, 2007

Enrollment Period

3.8 years

First QC Date

November 29, 2005

Last Update Submit

May 5, 2011

Conditions

Polyneuropathy

Keywords

Anti-MAG monoclonal gammopathyPolyneuropathyRituximab

Outcome Measures

Primary Outcomes (1)

  • INCAT sensory score at 1 year

    INCAT sensory score at 1 year

    during de study

Secondary Outcomes (4)

  • Functional scales, MRC score

    during the study

  • Quality of life (SF 36)

    during the study

  • Serum lymphocytes count, IgM level, anti-MAG antibody titers

    during the study

  • Electrophysiological parameters

    during the study

Study Arms (1)

1

EXPERIMENTAL

Rituximab

Drug: Rituximab

Interventions

RituximabDRUG

Rituximab

1

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IgM monoclonal gammopathy
  • Anti-MAG antibody titers \> 1.1000 BTU (ELISA)
  • Worsening polyneuropathy with INCAT score \> 4
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière, Consultation de Pathologie Neuromusculaire, Bâtiment Babinski

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 15934883BACKGROUND

MeSH Terms

Conditions

Polyneuropathies

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jean-Marc LEGER, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

April 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 6, 2011

Record last verified: 2007-03

Locations

FR(1)