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March 21, 2016

Long-term registries
Answering tough questions with big data?

Abstract

Over the past 2 decades, the treatment of multiple sclerosis (MS) has seen remarkable success in developing new therapies. Regulatory approval has been given to 9 different therapeutic entities. Given these treatment options, clinicians are faced with the challenge of deciding which therapy to recommend to individual patients.

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REFERENCES

1.
Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098–1107.
2.
Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087–1097.
3.
Spelman T, Kalincik T, Zhang A, et al. Comparative efficacy of switching to natalizumab in active multiple sclerosis. Ann Clin Transl Neurol 2015;2:373–387.
4.
Spelman T, Kalincik T, Jokubaitis V, et al. Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS. Neurol Clin Pract 2016;6:102–115.
5.
Butzkueven H, Kappos L, Pellegrini F, et al. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry 2014;85:1190–1197.

Information & Authors

Information

Published In

Neurology® Clinical Practice
Volume 6Number 2April 2016
Pages: 97-99

Publication History

Published online: March 21, 2016
Published in print: April 2016

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Disclosures

R.J. Fox receives consultant fees from Actelion, Biogen, MedDay, Novartis, Questcor, Teva, and Xenoport; served on advisory committees for Actelion, Biogen, and Novartis; receives research grant funding from Novartis; receives royalty fees for editing Multiple Sclerosis and Related Disorders (Demos Medical); and serves on the editorial boards for Neurology® and Multiple Sclerosis Journal. G. Cutter serves on data and safety monitoring boards for Apotek, Biogen, Cleveland Clinic (Vivus), GlaxoSmithKline Pharmaceuticals, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck/Ono Pharmaceuticals, Merck, Merck/Pfizer, Neuren, Sanofi-Aventis, Teva, Washington University, NHLBI (Protocol Review Committee), and NINDS, NICHD (OPRU oversight committee); serves on consulting or advisory Boards for Consortium of MS Centers (grant), D3 (Drug Discovery and Development), Genentech, Genzyme, Janssen Pharmaceuticals, Klein-Buendel Incorporated, Medimmune, Novartis, Opexa Therapeutics, Receptos, Roche, EMD Serono, Teva pharmaceuticals, TG Therapeutics Inc., and Transparency Life Sciences; and serves as a Contributing Editor to Neurology: Clinical Practice. Full disclosure form information provided by the author is available with the full text of this article at Neurology.org/cp.

Study Funding

No targeted funding reported.

Authors

Affiliations & Disclosures

Robert J. Fox, MD
Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH; and Department of Biostatistics (GC), University of Alabama at Birmingham School of Public Health.
Disclosure
Scientific Advisory Boards:
1.
Biogen Idec, Novartis
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
Editorial Board, Neurology Editorial Board, Multiple Sclerosis Journal
Patents:
1.
NONE
Publishing Royalties:
1.
Multiple Sclerosis and Related Disorders, Demos Medical, 2013
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
Actelion, Biogen Idec, MedDay, Novartis, Mallinckrodt, Teva, and XenoPort
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
Research grant from Novartis.
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
National MS Society, RC 1004-A-5, 2010- 2013; RG 4778-A-6, 2013-2018; NIH 1U01NS082329-01A1, 2013- 2018; Consortium of MS Centers
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
Gary Cutter, PhD
Mellen Center for Multiple Sclerosis (RJF), Cleveland Clinic, OH; and Department of Biostatistics (GC), University of Alabama at Birmingham School of Public Health.
Disclosure
Scientific Advisory Boards:
1.
Participation of Data and Safety Monitoring Committees: Apotek Biogen-Idec Cleveland Clinic(Vivus) Glaxo Smith Klein Pharmaceuticals Gilead Pharmaceuticals Modigenetech/Prolor Merck/Ono Pharmaceuticals Merck Merck/Pfizer Neuren Sanofi-Aventis Teva University of Kansas NHLBI (Protocol Review Committee) NINDS NICHD (OPRU oversight committee)
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
(1) Consortium of MS Centers, speaker honoraria; (2) Teva, Speaker honoraria
Editorial Boards:
1.
(1) Multiple Sclerosis, Editorial Board, 2010-present (2) JASN, 2013- present, statistical consulting reviewer (3) Alzheimers & Dementia: Translational Research & Clinical Interventions
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
(1) Employed by the University of Alabama at Birmingham; (2) President of Pythagoras, Inc. a private consulting company located in Birmingham AL.
Consultancies:
1.
Consortium of MS Centers (grant) Genentech Genzyme Jannsen Pharmaceuticals Klein-Buendel Incorporated Medimmune Novartis Nivalis Therapeutics Opexa Therapeutics Receptos Roche Somahlution EMD Serono Spiniflex Pharmaceuticals Teva pharmaceuticals Transparency Life Sciences
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
(1) NARCOMS MS Patient Registry
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
No direct grants, but work on studies funded to the Consortium of MS Centers subcontracted for analysis of NARCOMS Registry.
Research Support, Government Entities:
1.
ACTIVE U01 NS 042685 (Cutter) 09/23/2005 ? 08/31/2015 NIH/NINDS Thymectomy Plus Prednisone vs. Prednisone Alone in NonThymomatous Myasthenia Gravis This multinational clinical trial aims to assess the utility of thymectomy in treating nonthymomatous Myasthenia Gravis patients comparing surgery plus medications versus medications alone. P30-AI 027767 (Saag, M.) 06/01/2014 ? 05/31/2019 NIH/NIAID UAB Center for Aids Research This CFAR is organized as a partnership between the University of Alabama at Birmingham and the Southern Research Institute. The primary purpose of this partnership is to generate interdisciplinary AIDS research efforts. This Center is responsible for planning, evaluating, managing and documenting a broad array of research activities within two institutions. Particular emphasis is placed upon linking clinical and basic science studies through the use of shared facilities and to translate as quickly as possible fundamental knowledge about AIDS and its related disorders into clinical treatment and prevention programs. U01-HL 119242 (Cutter) 09/01/2014 ? 05/31/2020 NIH/NHLBI Chronic Hypertension and Pregnancy (CHAP): Data Coordinating Center We propose 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. The trial will be conducted in 12 experienced research-oriented Ob/Gyn departments (including 25 clinical sites) in the United States. The monitoring plan will include a pre-specified option to increase the planned sample size of 4700 women after interim evaluation by an independent Data Safety and Monitoring Board. R01 HD 064729 (Tita) 04/01/2010 ? 07/31/2015 NIH/NICHD Caesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) Trial A multicenter randomized trial to determine the efficacy and safety of a modified (extended-spectrum) antibiotic prophylaxis strategy at cesarean delivery to reduce surgical site infections. R01 AG 021927 (Marson) 07/01/2010 ? 06/30/2015 NIH/NIA Functional Change in Mild Cognitive Impairment (COINS) This R01 project investigates longitudinal change in higher order functional abilities in patients with MCI, and develops predictor models for clinical progression and conversion from MCI to dementia. No number assigned (Cutter) 01/01/2004 ? 12/31/2015 Consortium of MS Centers (CMSC) North American Research Consortium on Multiple Sclerosis (NARCOMS) The goals of this project are to facilitate a confidential way for patients to supply valuable information to researchers about their course of disease that may lead to more effective treatments and care. W81XWH-12-1-0155 (Korf) 05/15/2012 ? 05/14/2017 U.S. Department of Defense NEUTOFIBOMATOSIS CLINICAL CONSORTIUM AWARD 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. U01NS45719 (Lublin) 06/01/2004 ? 11/30/2015 NIH/NINDS CombiRx Statistical and Data Management Center A Phase III, multi-center, double-blind, randomized study comparing the combined use of Interferon Beta-1a and Glatiramer Acetate to either agent alone in patients with relapsing remitting multiple sclerosis. 140305 (Greenberg) 09/01/2013 ? 08/31/2016 Patient Centered Outcomes Research Institute Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate (CAPTURE) U34 AR062891 (K. Saag) 04/15/2013 ? 03/31/2015 NIH/NIAMS Effectiveness of DiscontinuinG BisphosphonatEs Study (EDGE) Planning grant for a Pragmatic Clinical Trial (PCT), ?Effectiveness of DiscontinuinG bisphosphonatEs (EDGE) Study?, a ?real world? effectiveness trial of an initially estimated 4,100 patients randomized to continuation or discontinuation of prior alendronate therapy. P30DK079337 (Agarwal) 09/20/13 ? 07/31/18 NIH/NIDDK UAB/UCSD O?Brien Core Center for Acute Kidney Injury Research 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. RSTFD0000541263 (Cutter) 09/01/13 ? 08/31/17 Children?s Hospital (Boston) Early Biomarkers of Autism Spectrum Disorders in Infants with Tuberous Sclerosis MG Registry (Cutter) 01/01/14-present (annually) MGFA This is new registry (1.5 years old) that is a patient registry of Myasthenia Gravis Patients based solely on patient reported outcomes tracking their disease over time. CBD Trial (Cutter) 04/01/2014 ? 9/30/2015 State of Alabama The data management center for the effectiveness of cannabidiol (CBD) oil for the treatment of seizures and epilepsy.
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
(1) Consortium of MS Centers (2) Myasthenia Gravis Foundation of America, grant for MG Registry
Stock/stock Options/board of Directors Compensation:
1.
Pythagoras, Inc. Sub S Corporation - President. Cre8FIT - Sub S corporation - Daughter's exercise facility - investor and part owner.
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.
Galderma Litigation (acne case) reviewed statistical data

Notes

Correspondence to: [email protected]
Funding information and disclosures are provided at the end of the article. Full disclosure form information provided by the author is available with the full text of this article at Neurology.org/cp.

Author Contributions

R. J. Fox: Drafting/revising the manuscript. G. Cutter: Drafting/revising the manuscript.

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Cited By
  1. Long-term follow-up of multiple sclerosis studies and outcomes from early treatment of clinically isolated syndrome in the BENEFIT 11 study, Journal of Neurology, 267, 2, (308-316), (2019).https://doi.org/10.1007/s00415-018-09169-w
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