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Abstract

Objective:

To determine whether rituximab 375 mg/m2 was efficacious in patients with immunoglobulin M (IgM) anti-myelin–associated glycoprotein antibody demyelinating neuropathy (IgM anti-MAG demyelinating neuropathy).

Methods:

Fifty-four patients with IgM anti-MAG demyelinating neuropathy were enrolled in this randomized, double-blind, placebo-controlled trial. The inclusion criteria were inflammatory neuropathy cause and treatment (INCAT) sensory score (ISS) ≥4 and visual analog pain scale >4 or ataxia score ≥2. The primary outcome was mean change in ISS at 12 months.

Results:

Twenty-six patients were randomized to a group receiving 4 weekly infusions of 375 mg/m2 rituximab, and 28 patients to placebo. Intention-to-treat analysis, with imputation of missing ISS values by the last observation carried forward method, showed a lack of mean change in ISS at 12 months, 1.0 ± 2.7 in the rituximab group, and 1.0 ± 2.8 in the placebo group. However, changes were observed, in per protocol analysis at 12 months, for the number of patients with an improvement of at least 2 points in the INCAT disability scale (p = 0.027), the self-evaluation scale (p = 0.016), and 2 subscores of the Short Form–36 questionnaire.

Conclusions:

Although primary outcome measures provide no evidence to support the use of rituximab in IgM anti-MAG demyelinating neuropathy, there were improvements in several secondary outcomes in per protocol analysis.

Level of evidence:

This study provides Class I evidence that rituximab is ineffective in improving ISS in patients with IgM anti-MAG demyelinating neuropathy.

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Supplementary Material

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Information & Authors

Information

Published In

Neurology®
Volume 80Number 24June 11, 2013
Pages: 2217-2225
PubMed: 23667063

Publication History

Received: October 18, 2012
Accepted: March 12, 2013
Published online: May 10, 2013
Published in print: June 11, 2013

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Disclosure

J.-M. Léger received departmental research grants or honoraria from Biogen-Idec, Baxter, CSL-Behring, LFB, Novartis, Octapharma, and Pfizer. K. Viala received departmental research grants or honoraria from CSL-Behring and LFB. G. Nicolas received honoraria from LFB, GSK, Novartis, and Debiopharm. A. Créange received departmental research grants from Bayer-Schering, Biogen-Idec, CSL-Behring, Genzyme-Sanofi, LFB, Merck-Serono, Novartis, and TevaPharma. J.-M. Vallat reports no disclosures. J. Pouget received departmental research grants and honoraria from CSL-Behring, Genzyme-Sanofi, LFB, and Octapharma. P. Clavelou received departmental research grants or honoraria from Actelion, Almirall, Bayer-Scherring, Biogen-Idec, CSL-Behring, Genzyme-Sanofi, GSK, LFB, Novartis, and TevaPharma. C. Vial received honoraria from LFB. A. Steck has consultancy for Actelion and Pfizer. L. Musset and B. Marin report no disclosures. Go to Neurology.org for full disclosures.

Study Funding

Supported by a grant from Ministère de la Santé (PHRC no 04049), Assistance-Publique Hôpitaux de Paris (Délégation Régionale à la Recherche Clinique; I. Brindel, M. Legrand), and Roche France provided the rituximab and placebo.

Authors

Affiliations & Disclosures

Jean-Marc Léger, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
Commercial entity CSL-Behring :Scientific Advisory Board LFB: Scientific Advisory Board Novartis: Scientific Advisory Board
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Revue Neurologique: Editorial Advisory Board from 2000 Presse Médicale: Editorial Advisory Board from 2002 European Journal of Neurology: Editorial Advisory Board from 2005 Journal of the Peripheral Nervous System: Associate Editor from 2000
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Commercial entity Biogen Idec Baxter Octapharma Pfizer
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Karine Viala, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
CSL Behring, LFB: commercial entities
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
CSL behring commercial entity
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Guillaume Nicolas, MD, PhD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
honoraria from LFB, GSK, Novartis and Debiopharm
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Alain Créange, MD, PhD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
(1)Bayer-Schering-Pharma, (2)Biogen-Idec, (3)CSL-Behring, (4)Genzyme-Sanofi, (5)LFB, (6)Merck-Serono, (7)Novartis, (8)TevaPharma
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Jean-Michel Vallat, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
French Minister of Health as a reference center for rare peripheral neuropathies : 2006 to 2011
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Jean Pouget, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
received speaker honoraria from LFB (bank)in 2011, 2012 received speaker honoraria from CSL Behring (bank)in 2011,2012
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
received honoraria from LFB (2012) received honoraria from Genzyme (2012)
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
therapeutic trial BIOGEN
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Pierre Clavelou, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
Novartis (non profit entity) Teva Pharma (non profit entity) Bayer Schering (non profit entity) Biogen Idec (non profit entity) Genzyme-Sanofi (non profit entity)
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Non profit entity, fund directly to department of neurology : Novartis, Teva Pharma, Biogen Idec, Merck Serono, Bayer Schering, LFB, Genzyme-Sanofi
Editorial Boards:
1.
Editorial Advisory Board : La letre du neurologue (french, no financial compensation, since four years)
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Christophe Vial, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
C VIAL received honoraria from LFB
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Andreas Steck, MD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
Pfizer
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
Talecris
Editorial Boards:
1.
Swiss Archives of Neurology and Psychiatry Muscle and Nerve as advisory board
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Actelion
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Lucile Musset, MD, PhD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Benoit Marin, MD, PhD
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
- Pole de Recherche et d'Enseignement Supérieur Limousin Poitou Charentes - French National Agency (Agence Nationale de la Recherche)
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
French National Research on Amyotrophic Lateral Sclerosis
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
For the RIMAG Study Group (France and Switzerland)
From the Department of Neurology (J.-M.L., K.V.) and Laboratory of Immunochemistry (L.M.), University Hospital Pitié-Salpêtrière, Paris; University of Angers (G.N.), Angers; University Hospital Henri-Mondor (A.C.), Créteil; University Hospital Dupuytren (J.-M.V.), Limoges; University Hospital La Timone (J.P.), Marseille; University of Clermont-Ferrand (P.C.), Clermont-Ferrand; University Hospital Pierre Wertheimer (C.V.), Lyon, France; University of Basel (A.S.) Basel, Switzerland; and CHU Limoges, Unit of Clinical Research and Biostatistics, and Inserm UMR1094, Tropical Neuroepidemiology (B.M.), Limoges, France.

Notes

Correspondence to Dr. Léger: [email protected]
Coinvestigators are listed on the Neurology® Web site at www.neurology.org.
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

Author Contributions

Jean-Marc Léger: drafting/revising the manuscript, study concept or design, analysis or interpretation of data, acquisition of data, study supervision. Karine Viala: drafting/revising the manuscript, study concept or design, acquisition of data. Guillaume Nicolas: drafting/revising the manuscript, acquisition of data. Alain Créange: drafting/revising the manuscript, study concept or design, acquisition of data, study supervision. Jean-Michel Vallat: study concept or design, analysis or interpretation of data, acquisition of data. Jean Pouget: analysis or interpretation of data, acquisition of data. Pierre Clavelou: drafting/revising the manuscript, acquisition of data. Christophe Vial: drafting/revising the manuscript, acquisition of data. Andreas Steck: study concept or design, obtaining funding. Lucile Musset: analysis or interpretation of data. Benoit Marin: drafting/revising the manuscript, study concept or design, analysis or interpretation of data, statistical analysis.

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