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May 2021; 8 (3) ArticleOpen Access

Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder

Romain Marignier, Jeffrey L. Bennett, Ho Jin Kim, Brian G. Weinshenker, Sean J. Pittock, Dean Wingerchuk, Kazuko Fujihara, Friedemann Paul, Gary R. Cutter, Ari J. Green, Orhan Aktas, Hans-Peter Hartung, Fred D. Lublin, Ian M. Williams, Jorn Drappa, Dewei She, Daniel Cimbora, William Rees, Michael Smith, John N. Ratchford, Eliezer Katz, Bruce A.C. Cree
First published March 26, 2021, DOI: https://doi.org/10.1212/NXI.0000000000000978
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Article Information

vol. 8 no. 3 e978
DOI: 
https://doi.org/10.1212/NXI.0000000000000978
PubMed: 
33771837
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received September 23, 2020
  • Accepted in final form January 8, 2021
  • First Published March 26, 2021.
Copyright & Usage: 
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Author Disclosures

    1. Romain Marignier, MD, PhD,
    2. Jeffrey L. Bennett, MD, PhD,
    3. Ho Jin Kim, MD, PhD,
    4. Brian G. Weinshenker, MD,
    5. Sean J. Pittock, MD,
    6. Dean Wingerchuk, MD,
    7. Kazuko Fujihara, MD,
    8. Friedemann Paul, MD,
    9. Gary R. Cutter, PhD,
    10. Ari J. Green, MD, MCR,
    11. Orhan Aktas, MD,
    12. Hans-Peter Hartung, MD,
    13. Fred D. Lublin, MD,
    14. Ian M. Williams, PhD,
    15. Jorn Drappa, MD, PhD,
    16. Dewei She, PhD,
    17. Daniel Cimbora, PhD,
    18. William Rees, PhD,
    19. Michael Smith, PhD,
    20. John N. Ratchford, MD,
    21. Eliezer Katz, MD and
    22. Bruce A.C. Cree, MD, PhD, MAS
    23. on behalf of the N-MOmentum Study Investigators
  1. Romain Marignier, MD, PhD,
    2. Scientific Advisory Boards:

    1. Dr Marignier is serving on a scientific advisory board of Viela Bio

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Romain Marignier has received lecturing fees and travel grants from Biogen, Genzyme, Novartis, Merck Serono, Roche, Sanofi Aventis and Teva Pharma

    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

  2. Jeffrey L. Bennett, MD, PhD,
    3. Scientific Advisory Boards:

    1. Clene Neuroscience Roche

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. Editorial Board, Journal of Neuro-ophthalmology Editorial Board, Multiple Sclerosis Journal Editorial Board, Neurology: Neuroimmunology & Neuroinflammation

    Patents:

    1. (1) Compositions and Methods for the Treatment of Neuromyelitis Optica; novel blocking monoclonal therapy for neuromyelitis optica: US Patent: 10,654,916

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) Reistone-Bio (2) Viela Bio (3) Clene Nanomedicine (4) Chugai Pharma USA (5) Mitsubishi Tanabe (6) AbbVie (6) Alexion Pharmaceuticals (7) Genentech-Roche (8) Antigenomycs (9) TG Therapeutics (10) Novartis

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Mallinckrodt Pharmaceuticals (2) Novartis (3) Antigenomycs

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) National Institutes of Health (NEI, NINDS)

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. (1) Aquaporumab, rights for future royalty payments

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Ho Jin Kim, MD, PhD,
    4. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Received travel expenses and/or honoraria for lectures or educational activities from Alexion, Biogen, Celltrion, Eisai, GC Pharma, Merck Serono, Novartis, Sanofi Genzyme, Teva-Handok, and Viela Bio

    Editorial Boards:

    1. Multiple Sclerosis Journal, Coeditor, 2019 Journal of Clinical Neurology, Associate Editor, 2016

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Aprilbio, HanAll BioPharma, MDimune, Merck Serono, Sanofi Genzyme, and Viela Bio

    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. National Research Foundation of Korea, 2018R1A5A2023127, , Co-Principal Investigator, 2018

    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

  4. Brian G. Weinshenker, MD,
    5. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. 1. Roche, honoraria for participation in symposia regarding neuromyelitis optica, World Congress of Neurology 2019

    Editorial Boards:

    1. 1. Canadian Journal of Neurological Sciences, editorial board member, 2006-present; no compensation 2. Turkish Journal of Neurology, editorial board member, 2005-present; no compensation

    Patents:

    1. 1) NMO-IgG for diagnosis of neuromyelitis optica; application 20050112116; patent issued and technology licensed to R.S.R. Ltd.,Oxford University,MVZ Labor PD Dr. Volkmann und Kollegen GbR, Hospices Civil de Lyon

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. 1. Chugai: consulting regarding interpretation of neuromyelitis optica clinical trial 2. Mitsubishi Tanabe: consulting regarding design of neuromyelitis optica clinical trial

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. (1)VielaBio Pharmaceuticals, Adjudication Committee Member (2)Alexion Pharmaceuticals, Adjudication Committee Member

    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. Guthy Jackson Charitable Foundation, sponsor of research in NMO, 10/2008-08/2017

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NMO-IgG for diagnosis of neuromyelitis optica; patent issued and technology licensed to R.S.R. Ltd., Oxford University, MVZ Labor PD Dr. Volkmann und Kollegen GbR and Hospices Civil de Lyon

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  5. Sean J. Pittock, MD,
    6. Scientific Advisory Boards:

    1. Alexion Pharmaceutical Advisory Board Medimmune/Viele Bio Advisory Board UCB pharmaceuticals Astellas

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. Dr. Pittock has a patent Patent# 8,889,102 (Application#12-678350) - Neuromyelitis Optica Autoantibodies as a Marker for Neoplasia issued, and a patent Patent# 9,891,219B2 (Application#12-573942) - Methods for Treating Neuromyelitis Optica (NMO) by Administration of Eculizumab to an individual that is Aquaporin-4 (AQP4)-IgG Autoantibody positive issued. Dr Pittock has a patent pending for GFAP, Septin-5, Kelch11 and MAP1B autoantibodies as biomarkers of neurological autoimmunity.

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Dr. Pittock has provided consultation to Alexion Pharmaceuticals and Medimmune/Viela Bio but has received no personal fees or personal compensation for these consulting activities. All compensation for consulting activities is paid directly to Mayo Clinic.

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. No activity to report. I am a salaried employee of Mayo Clinic and salary is fixed specialty dependent and not impacted by test volume or laboratory income.

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Dr Pittock has received research funding from Grifols, Medimmune/Viela Bio, Alexion and AEA (Autoimmune Encephalitis Associations).

    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

  6. Dean Wingerchuk, MD,
    7. Scientific Advisory Boards:

    1. (1) VielaBio (2) Roche

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. (1) The Neurologist, Co-Editor-in-Chief, 2014-present.

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) MedImmune, (2) Novartis, (3) Biogen; (4) Celgene; (5) Genentech; (6) TG Therapeutics; (7)Third Rock Ventures; (8)Reistone

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1) Alexion,(2) TerumoBCT

    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

  7. Kazuko Fujihara, MD,
    8. Scientific Advisory Boards:

    1. Serves on scientific advisory boards for Biogen, Mitsubishi Tanabe, Novartis, Chugai, Ono, Nihon,Alexion, and VielaBio.

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. has received funding for travel or speaker honoraria from Chugai, Bayer, Biogen, Mitsubishi Tanabe, Ono, Nihon, Asahi Kasei, Novartis, Merck, Vielabio/MedImmune, Eisai, Astellas, Takeda, Daiichi Sankyo, and Cosmic Corporation

    Editorial Boards:

    1. Serve as an editorial board member of Clinical and Experimental Neuroimmunology (2009-present), Frontiers in Neurology (2017-present), Neurology: Neuroimmunology and Neuroinflammation (2018-present), Multiple Sclerosis and Related Disorders (2020-present) and a advisory board member of Sri Lanka journal of Neurology.

    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. funded as the investigator (2010–2020) by the Grants- in-Aid for Scientific Research from the Ministry of Education, Science and Technology of Japan and as the secondary investigator by the Grants-in-Aid for Scientific Research from the Ministry of Health, Welfare and Labor of Japan (2010–present).

    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

  8. Friedemann Paul, MD,
    9. Scientific Advisory Boards:

    1. Novartis OCTIMS study steering committee MedImmune / Viela Bio steering committee

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. speaker honoraria and travel grants from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis / Genzyme, and Merck Serono, Alexion, Chugai, MedImmune, Shire, Roche, Actelion, Celgene

    Editorial Boards:

    1. Academic Editor, PLoS ONE Associate Editor, Neurology Neuroimmunology and Neuroinflammation

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. consultancies for SanofiGenzyme, BiogenIdec, MedImmune, Shire, Alexion

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Research support from from Bayer, Novartis, Biogen Idec, Teva, Sanofi-Aventis / Genzyme, Alexion and Merck Serono

    Research Support, Government Entities:

    1. German Research Council (DFG Exc 257), Werth Stiftung of the City of Cologne, German Ministry of Education and Research (BMBF Competence Network Multiple Sclerosis), Arthur Arnstein Stiftung Berlin, EU FP7 Framework Program (combims.eu)

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Arthur Arnstein Foundation Berlin, Guthy Jackson Charitable Foundation, National Multiple Sclerosis Society of the USA

    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

  9. Gary R. Cutter, PhD,
    10. Scientific Advisory Boards:

    1. Data and Safety Monitoring Boards: Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Horizon Pharmaceuticals,Hisun Pharmaceuticals, Mapi Pharmaceuticals LTD, Merck, Merck/Pfizer, Opko Biologics, OncoImmune, Neurim, Novartis, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Teva pharmaceuticals, VielaBio Inc, Vivus, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee).

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Medday, Neurogenesis, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion Pharmaceuticals, Roche, Somahlution, TG Therapeutics.

    Editorial Boards:

    1. Am journal of the Society of Nephrology. Statistical Reviewer; contributinng statistical help (4 yrs); Alzheimer's and Dementia (3) yrs; Neurology Clinical Practice (5yrs)

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Medday, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Roche, TG Therapeutics.

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. President of Pythagoras Inc. a consulting company...gc

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U19-AI113212 Name of Principal Investigator: Gary Cutter Funding Source: NIH/NIAID Title of Project (or Subproject):The UAB STI CRC- DiSCIS Biostatistics & Bioinformatics Core Dates of Approved/Proposed Project: 6/15/2014 – 5/31/2019 Annual Direct Costs: $1,418,940 Percent Effort: 1% What are the specific aims of this project? This study establishes a Sexually Transmitted Infections Cooperative Research Center comprised of a group of innovative, multidisciplinary translational research projects with the goal of addressing the microbial origins and pathogenesis of the most prevalent genital discharge syndromes in men (non-gonococcal urethritis) and women (bacterial vaginosis), as well as the interaction of these syndromes with the most prevalent sexually transmitted bacteria, Chlamydia trachomatis. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01-HL119242 Name of Principal Investigator: Gary Cutter Funding Source: NIH/NHLBI Title of Project (or Subproject): Chronic Hyperten- sion and Pregnancy (CHAP): Data Coordinating Center Dates of Approved/Proposed Project: 9/1/2014 – 11/30/2020 Annual Direct Costs: $399,734 Percent Effort: 7.5% What are the specific aims of this project? This is a large pragmatic multi-center randomized trial of pregnant women with mild chronic hypertension to evaluate the benefits and harms of antihypertensive therapy to a goal <140/90 mmHg (as recommended for the general population in the US) compared with ACOG's current policy of expectant management of mild chronic hypertension in pregnancy. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Project Number: W81XWH-12-1-0155 Name of Principal Investigator: Bruce Korf Funding Source: U.S. Department of Defense Title of Project (or Subproject): Neurofibromatosis Clinical Consortium Award Dates of Approved/Proposed Project: 5/15/2012 – 5/14/2019 Annual Direct Costs: $333,333 Percent Effort: 3% What are the specific aims of this project? This is a cooperative study group that is focusing on multiple trials in NF. The role of the operations center is both as the data center and the overall coordinating of the study group. (NF) NAME OF PROFESSIONAL: Agarwal Is this project active or pending? Active Project Number: P30 DK079337 Name of Principal Investigator: Anupam Agarwal Funding Source: NIH/NIDDK Title of Project (or Subproject): UAB/UCSD O’Brien Core Center for Acute Kidney Injury Research Dates of Approved/Proposed Project: 9/20/2013 – 7/31/2019 Annual Direct Costs: $923,595 Percent Effort: 5% What are the specific aims of this project? In summary, these cores and the outstanding cohort of investigators assembled for this center will provide unique expertise that is critical for innovative and productive research in AKI. With its Extended Research Base, that includes both clinical and basic investigators, this O'Brien center will accelerate the translation of new investigative insights towards novel therapies for patients with AKI. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: P2C HD086851 Name of Principal Investigator: Bamman, MM Funding Source: NIH/NICHHD Title of Project (or Subproject): Rehabilitation Research Resource to Enhance Clinical Trials (REACT) Dates of Approved/Proposed Project: 9/17/2015 – 6/30/2020 Annual Direct Costs:$1,052,737 Percent Effort: 15% What are the specific aims of this project? There are major knowledge gaps in medical rehabilitation that demand clinical trials of the highest quality. With particular emphasis on chronic conditions such as stroke, brain or spinal cord injury, orthopedic and joint conditions, and developmental and degenerative disorders leading to disability, the overarching purpose of the P2C Medical Rehabilitation Research Resource, based at The University of Alabama at Birmingham (UAB), is to catalyze high-impact clinical trials that will define optimal rehabilitation strategies. (P2C) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active. (turned over remove) Project Number: U01 EY025858 Name of Principal Investigator: Kristina Visscher Funding Source: NIH/National Eye Institute Title of Project (or Subproject): Changes in Visual Cortical Connectivity Following Central Visual Field Loss Dates of Approved/Proposed Project: 5/1/2016 – 4/30/2020 Annual Direct Costs: $544,961 Percent Effort: 1% What are the specific aims of this project? When people lose central vision, they must use peripheral vision to do Daily tasks like reading and recognizing faces. This proposal will examine how changes in the connectivity and structure of early visual cortex relate to this huge shift in experience. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01 NS092595 Name of Principal Investigator: Martina Bebin Funding Source: NIH/NINDS Title of Project (or Subproject): Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex Dates of Approved/Proposed Project: 8/4/2016 – 8/3/2021 Annual Direct Costs:$1,792,413 Percent Effort: 5% What are the specific aims of this project? The primary objective of the study is the developmental impact of early versus delayed treatment with vigabatrin at 24 months of age based on the cognitive assessment score of the Bayley-III. (PREVENT) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: No Number Name of Principal Investigator: John Corboy Funding Source: NIH/University of Colorado Title of Project (or Subproject): Can People in Later Stages of MS Stop Taking Disease-Modifying Therapies? (The DISCO-MS Trial) Dates of Approved/Proposed Project: 5/16/2016 – 9/30/2022 Annual Direct Costs: $750,827 Percent Effort: 1% What are the specific aims of this project? This study randomizes to continue Rx or discontinuation in an older subpopulation of MS patients, to determine if DMT discontinuation is safe and results in no worse outcomes. (PCORI) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: UH3 NS100553 Name of Principal Investigator: Harrison Walker Funding Source: NIH Title of Project (or Subproject): Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson’s Disease Dates of Approved/Proposed Project: 9/30/2016 – 6/30/2022 Annual Direct Costs: $1,165,696 Percent Effort: 10% What are the specific aims of this project? The goal of this research is to use minimally invasive, patient-specific cortical physiology elicited by DBS to guide the use of emerging segmented (“directional”) DBS electrode technology in patients with Parkinson’s disease. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: R01 HD088646 Name of Principal Investigator: Anup Katheria Funding Source: National Institute of Health Title of Project (or Subproject): Premature Infants Receiving Cord Milking Or Delayed Cord Clamping Dates of Approved/Proposed Project: 4/1/2017 – 3/31/2022 Annual Direct Costs: $557,186 Percent Effort: 2.5% What are the specific aims of this project? Delayed cord clamping reduces overall bleeding in the brain of premature infants, but not the most severe types. “Milking” the umbilical cord, a method used to transfer blood from the placenta into the baby before the umbilical cord is clamped, may provide additional blood volume to the brain and other vital organs thereby reducing bleeding in the brain and improving long-term outcomes in premature babies. This study will determine whether umbilical cord milking reduces bleeding in the brain or death in premature newborns delivered by Cesarean section compared to delaying clamping of the umbilical cord. (PREMOD2) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: R01 CA217179 Name of Principal Investigator: James M. Markert Funding Source: National Institute of Health Title of Project (or Subproject): A Phase 1 Study of M032, A Genetically Engineered Hsv-1 Expressing Il-12, In Patients With Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, Or Gliosarcoma Co-Investigator - Cutter Dates of Approved/Proposed Project: 5/1/2017 – 4/30/2020 Annual Direct Costs: $411,318 Percent Effort: 1.5% What are the specific aims of this project? High-grade malignant gliomas are the most prevalent intracranial malignant brain tumor in adults with a dismal prognosis evidenced by a 12-15 month median survival and a 5-year survival <5%, evincing the need for more effective therapies. We created a novel, oncolytic Herpes Simplex Virus (oHSV) termed M032 (NSC 733972) that expresses human Interleukin-12 and the NExT (NCI) program manufactured clinical grade M032 (>560 doses) for which we have been issued an investigational new drug approval (#14,946) by the FDA. We propose to conduct a first-in-human Phase I clinical trial (NCT02062827) to assess the safety and tolerability of M032, to define any unexpected toxicities, to obtain correlative biologic information, and to determine a Recommended Phase 2 Dose. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: RG-1609-25966 Name of Principal Investigator: Robert Motl Funding Source: National Multiple Sclerosis Society Title of Project (or Subproject): Project BIPAMS: Behavioral Intervention for Increasing Physical Activity in MS Dates of Approved/Proposed Project: 8/1/2017 – 7/31/2020 Annual Direct Costs: $229,200 Percent Effort: 1% What are the specific aims of this project? BIPAMS is a pilot randomized controlled trial (RCT) for a preliminary evaluation supervised, aerobic exercise training can yield improvements in physical and cognitive functioning, compared with a waitlist control condition, that are associated with an increase in aerobic fitness among older adults with MS. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01 AR071133 Name of Principal Investigator: Bamman, MM Funding Source: NIH/NIAMSD Title of Project (or Subproject): The Exercise and Physical Activity Collaborative Team (ExPact): A Proposed MoTrPAC Clinical Center Dates of Approved/Proposed Project: 12/6/2016 – 11/30/2022 Annual Direct Costs: $2,114,297 Percent Effort: 3.5% What are the specific aims of this project? The goals are to help lead the NIH Common Fund initiative – Molecular Transducers of Physical Activity Consortium (MoTrPAC) – by serving as one of six adult clinical centers conducting a large-scale, randomized, controlled trial (RCT) of resistance vs. aerobic exercise training vs. no-exercise control. The RCT will be complemented by molecular acute response studies in RCT participants as well as highly trained athletes; all with the goal of generating molecular maps that reveal key underpinnings of exercise-induced health benefits. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: U01 HL133232 Name of Principal Investigator: Duncan Funding Source: NIH/NHLBI Title of Project (or Subproject): Autoantibody-Targeted Therapy for Acute Exacerbations of Idiopathic Pulmonary Fibrosis Dates of Approved/Proposed Project: 9/1/2017 – 7/31/2022 Annual Direct Costs: $667,856 Percent Effort: 5% What are the specific aims of this project? This is a multicenter, randomized clinical trial to test specific autoantibody reduction therapies, vs. treatment as usual, in patients with acute exacerbations of idiopathic pulmonary fibrosis. Aims of this project are: 1) To conduct the trial, and compare six-month survival of the two arms; and 2) To compare effects of the treatments on secondary endpoints of a) global autoantibody levels, and b) functional assessments with 6 minute walk tests, and c) adverse events; and 3) To conduct basic immunological studies to define characteristics of the autoimmune responses in these patients that can be used to personalize therapy. (STRIVE) NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: UAB# 517425 Name of Principal Investigator: Brian Sandroff Funding Source: Serono Title of Project (or Subproject): Effects of Walking Exercise Training on Learning and Memory Outcomes in MS Dates of Approved/Proposed Project: 10/1/2017 – 9/30/2020 Annual Direct Costs: $367,687 Percent Effort: 1% What are the specific aims of this project? Cognitive impairment is highly prevalent, disabling, and poorly managed in persons with multiple sclerosis (MS) and exercise training might represent a promising approach for better managing this symptom of the disease. Treadmill walking has recently been identified as the exercise modality that might exert the greatest beneficial effects on cognition in MS. This investigation will provide data on potential mechanisms for how chronic exercise training might improve cognition in persons with MS NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: UAB #517503 Name of Principal Investigator: Saag, K Funding Source: Horizon Pharma USA, Inc. Title of Project (or Subproject): Reducing Immunogenicity to PegloticasE (RECIPE) Dates of Approved/Proposed Project: 10/23/2017 – 10/22/2020 Current Year Direct: $618,793 Percent Effort: 12.5% What are the specific aims of this project? Double-blind, randomized, multicenter Phase II trial to evaluate preliminary efficacy of a short course of immunosuppressive therapy to prevent immunogenicity conferred by pegloticase. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: P01HL136267 Name of Principal Investigator: Pollock Funding Source: NIH/NHLBI Title of Project (or Subproject): Integrating Novel Mechanisms Controlling Sodium Excretion and Blood Pressure Dates of Approved/Proposed Project: 05/01/2017 – 03/31/2022 Annual Direct Costs: $1,756,435 Percent Effort: 5% What are the specific aims of this project? This PPG focuses on elucidating mechanisms by which the kidney controls sodium excretion, and therefore, has direct relevance to the serious health problem of salt-dependent hypertension and kidney disease. The three main projects each utilize relevant animal models and sophisticated in vitro techniques to uncover the pathways that lead to salt-dependent high blood pressure as well as uncovering ways to combat significant side effects of the relevant class of drugs known as endothelin receptor antagonists. We expect these studies will be important in guiding future clinical and therapeutic practices for a broad range of cardiovascular and related diseases NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: R01AG057684 Name of Principal Investigator: Kennedy Funding Source: NIH/NIA Title of Project (or Subproject): In Silico Screening of Medications for Slowing Alzheimer’s Disease Progression Dates of Approved/Proposed Project: 09/15/2017 – 03/31/2022 Annual Direct Costs: $482,787 Percent Effort: 10% What are the specific aims of this project? In this proposal, we will explore drug repurposing, in which medications approved to treat other illnesses are evaluated for potential benefits in Alzheimer's disease (AD), to improve the efficiency of the drug development process, which currently ends in failure for most candidate medications despite considerable investment of both time and resources. We will apply data mining, or pattern recognition, algorithms to the concomitant medications taken by subjects in previous AD clinical trials that are part of our meta-database of more than 6,500 individuals and by participants in Medicare Part D with more than 787,000 individuals. This approach will allow us to screen hundreds of drugs for effects in slowing the progression of AD, which will guide future clinical trials of novel therapeutic agents. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active (remove turned over) Project Number: UM1 AI68636 Name of Principal Investigator: Shacka Funding Source: NIH/Brigham& Women’s Hospital Title of Project (or Subproject): Autophagy- Lysosome Pathway Function in HIV: Effects of Antiretroviral Therapy and Relevance to Neuro- cognitive Status Dates of Approved/Proposed Project: 6/1/2017 – 5/31/2019 Annual Direct Costs: $100,000 Percent Effort: 0.08% What are the specific aims of this project? The specific aims of this project are to determine if cathepsin, cystatin B and cystatin C levels are increased in monocytes and T-cells of ART-naïve, HIV+ participants with cognitive impairment and if these putative baseline differences are attenuated by ART; and to determine if autophagic flux is inhibited in monocytes and T-cells of ART-naïve, HIV+ participants with cognitive impairment and if these putative baseline differences are attenuated by ART. NAME OF PROFESSIONAL: Gary Cutter Is this project active or pending? Active Project Number: 1R01DK108438-01 Name of Principal Investigator: Overton Funding Source: NIH/NIDD Title of Project (or Subproject): Effect of Pitavastatin on Kidney Function in HIV-infected Persons Dates of Approved/Proposed Project: 09/21/2015 – 06/30/2020 Annual Direct Costs: $466,683 Percent Effort: 1% What are the specific aims of this project? In this proposal, we will evaluate the kidney protective effect of pitavastatin and assess mechanistic pathways through which it works. We hope the results of this project will have the potential to change the management and prevention of CKD in the setting of HIV infection. (Effort in year 4)  

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. The MG Registry receives funding from the Myasthenia Gravis Foundation of America

    Stock/Stock Options/Board of Directors Compensation:

    1. Consortium of MS Centers - Immediate past President - only expenses covered

    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

  10. Ari J. Green, MD, MCR,
    11. Scientific Advisory Boards:

    1. Medimmune End Point adjudication committee, Novartis Pharmaceuticals OCTIMS steering committee, Inception 5 Sciences Advisor and Steering Committee, Pipeline Pharmaceuticals Advisor, Bionure Scientfic Advisory Board

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. JAMA Neurology Associate Editor Neurology Editorial Board December 2010-2015

    Patents:

    1. Remyelination molecules and pathways Eye movement monitoring for MS

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Pipeline Therapeutics

    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. NINDS R01 NS088155 NIA 2R01AG038791-06A1 NIH R01 NS105741

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. National MS Society Sherak Foundation Hilton Foundation

    Stock/Stock Options/Board of Directors Compensation:

    1. Pipeline Bionure

    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. Mylan Pharmaceuticals/Synthon/Pharmasciences v Teva Pharmaceuticals Expert Witness

  11. Orhan Aktas, MD,
    12. Scientific Advisory Boards:

    1. (1) Medimmune Scientific Advisory Board

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. (1) Bayer, speaker honoraria (2) Novartis, speaker honoraria (3) Biogen, travel and speaker honoraria (4) Merck Serono, travel and speaker honoraria (5) Teva, speaker honoraria (6) Sanofi-Genzyme, speaker honoraria (7) Roche, travel and speaker honoraria (8) Almirall, speaker honoraria (9) Alexion, travel and speaker honoraria (10) Celgene, travel and speaker honoraria

    Editorial Boards:

    1. (1) PLoS ONE, Academic Editor, since 2012

    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) Biogen (2) Novartis

    Research Support, Government Entities:

    1. (1) German Ministry of Science (BMBF), PI for NationNMO/KKNMS (NationNMO‐PAT FKZ 01GI1602B), since 2016

    Research Support, Academic Entities:

    1. (1) German Research Foundation (DFG), PI in GRK2578, since 2020

    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

  12. Hans-Peter Hartung, MD,
    13. Scientific Advisory Boards:

    1. Novartis; Merck Serono; Teva; Biogen; Roche; Genzyme; BayerHealthcare; Sanofi; MedImmune; GeNeuro; Octapharma; Receptos Celgene; Roche; CSL Behring; TG Therapeutics; Viela Bio

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Speaker Honoraria from: Biogen Genzyme Merck Novartis Roche

    Editorial Boards:

    1. editorial board member (unpaid): CNS Drugs; Frontiers Neurology / Immunology; European Neurology; Current Opinion in Neurology; Nature Reviews Neurology; Therapeutic Advances in Neurological Disorders; Journal of Neuroinflammation

    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

  13. Fred D. Lublin, MD,
    14. Scientific Advisory Boards:

    1. Biogen; EMD Serono; Novartis; Teva; Actelion; Sanofi/Genzyme; Acorda; Roche/Genentech; MedImmune/ Viela Bio; Receptos/Celgene; Medday; Atara Biotherapeutics; Mapi Pharma; Innate Immunotherapeutics; Apitope; Orion Biotechnology; Brainstorm Cell Therapeutics; Jazz Pharmaceuticals; GW Pharma; Mylan; Immunic; Population Council; Avotres; Neurogene

    Gifts:

    1. NONE

    Funding for travel or speaker honoraria:

    1. Most, if not all, consulting activity and scientific boards listed above and below involved travel, all before March 2020, that was either paid for directly or reimbursed.

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Same as Advisory Boards

    Speakers' Bureaus:

    1. Sanofi Genzyme- non-promotional EMD Serono- non-promotional

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Novartis; Actelion; Biogen; Sanofi, NMSS, NIH; Brainstorm Cell Therapeutics

    Research Support, Government Entities:

    1. 1) NIH/NINDS- PI, 2018-2021 2) NIH/NINDS- PI, 2018-2021

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. 1) National Multiple Sclerosis Society- PI, 2014-2019 2) National Multiple Sclerosis Society- PI 2019-2024

    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. Stock Options- no value assigned; Avotres

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. I have provided occasional expert testimony in various matters

  14. Ian M. Williams, PhD,
    15. 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. Oxford PharmaGenesis Ltd, Communications Consultant, 5 years

    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

  15. Jorn Drappa, MD, PhD,
    16. 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. Viela Bio, Chief Medical Officer, 3 years

    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. Viela Bio, 3 years

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  16. Dewei She, PhD,
    17. 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. Viela Bio, 5/2018 - present

    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

  17. Daniel Cimbora, PhD,
    18. 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. Viela Bio, clinical scientist, 2 years

    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

  18. William Rees, PhD,
    19. Scientific Advisory Boards:

    1. NONE

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. NONE

    Editorial Boards:

    1. NONE

    Patents:

    1. 2 patent applications related to the N-MOmentum study.

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. (1) Viela Bio, VP Translational Sciences, 3 years (2) Medimmune, Principal Scientist, 3 years

    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

  19. Michael Smith, PhD,
    20. 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. Viela Bio, Bioinformatics Scientist, 2 years

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. I am an employee of Viela Bio

    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. Viela Bio

    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

  20. John N. Ratchford, MD,
    21. 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. Dr. Ratchford was an employee of Viela Bio during the period of the study.

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Dr. Ratchford was an employee of Viela Bio during the period of the study.

    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. Dr. Ratchford holds stock and stock options in Viela Bio. Stock/Stock Options, Medical Equipment & Materials: Dr. Ratchford holds stock and stock options in Viela Bio.

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  21. Eliezer Katz, MD and
    22. 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. 1. Medimmune - 2013-2018 2. Viela Bio - 3/2018- present I am Clinical lead on NMOSD clinical trial and in this capacity I am a contributing author

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other activities:

    1. I am full time employee of Viela bio.

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. I am a full time employee of Viela Bio

    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. I received stocks of Viela Bio and AstraZenica, and currently holding stocks of Viela Bio only.

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Medimmune/Astazeneca 2013-2018 Viela Bio 2018-present

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  22. Bruce A.C. Cree, MD, PhD, MAS
    23. 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. Alexion, Atara, Autobahn, Biogen, EMD Serono, Novartis, Sanofi and TG Therapeutics

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Genentech

    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

  1. From the Service de Neurologie Sclérose en Plaques (R.M.), Pathologies de La Myéline et Neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, France; University of Colorado School of Medicine (J.L.B.), Anschutz Medical Campus, Aurora; Research Institute and Hospital of National Cancer Center (H.J.K.), Goyang, South Korea; Mayo Clinic (B.G.W., S.J.P.), Rochester, MN; Mayo Clinic (D.W.), Scottsdale, AZ; Department of Multiple Sclerosis Therapeutics (K.F.), Fukushima Medical University and Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama, Japan; Experimental and Clinical Research Center (F.P.), Max Delbrück Center for Molecular Medicine and Charité—Universitätsmedizin Berlin, Germany; University of Alabama at Birmingham (G.R.C.); UCSF Weill Institute for Neurosciences (A.J.G.), Department of Neurology and Department of Ophthalmology, University of California San Francisco; Medical Faculty (O.A., H.-P.H.), Heinrich Heine University, Düsseldorf, Germany; Icahn School of Medicine at Mount Sinai (F.D.L.), New York; Oxford PharmaGenesis Ltd (I.M.W.), UK; Viela Bio (J.D., D.S., D.C., W.R., M.S., J.N.R., E.K.), Gaithersburg, MD; and UCSF Weill Institute for Neurosciences (B.A.C.C.), University of California San Francisco.
  1. Correspondence
    Dr. Marignier romain.marignier{at}chu-lyon.fr
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