Erratum: Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial (The Lancet (2016) 387(10023) (1075–1084) (S0140673615013148) (10.1016/S0140-6736(15)01314-8));Oral fingolimod in primary progressive multiple sclerosis (INFORMS): A phase 3, randomised, double-blind, placebo-controlled trial

The Lancet

Volumn 387, Issue 10023, 2016, Pages 1075-1084

  Lublin, Fred ^a   Miller, David H ^b   Freedman, Mark S ^c   Cree, Bruce A C ^d   Wolinsky, Jerry S ^e   Weiner, Howard ^f   Lubetzki, Catherine ^g   Hartung, Hans Peter ^h   Montalban, Xavier ⁱ   Uitdehaag, Bernard M J ^j   Merschhemke, Martin ^k   Li, Bingbing ^k   Putzki, Norman ^k   Liu, Fonda C ^k   Häring, Dieter A ^k   Kappos, Ludwig ^l  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^d UCSF Multiple Sclerosis Center   (United States)

^e UNIVERSITY OF TEXAS   (United States)

^f HARVARD MEDICAL SCHOOL   (United States)

^g SORBONNE UNIVERSITÉ   (France)

^h Department of Orthopedic Surgery   (Germany)

ⁱ HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^j VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^k NOVARTIS PHARMA AG   (Switzerland)

^l UNIVERSITY HOSPITAL BASEL   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; CHOLESTEROL; FINGOLIMOD; GAMMA GLUTAMYLTRANSFERASE; LOW DENSITY LIPOPROTEIN; PLACEBO; TRIACYLGLYCEROL; IMMUNOSUPPRESSIVE AGENT;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGINA PECTORIS; ARTHRALGIA; ARTICLE; ATRIOVENTRICULAR BLOCK; BACKACHE; BACTERIAL CYSTITIS; BASAL CELL CARCINOMA; BRADYCARDIA; BREAST CANCER; BRONCHITIS; BRONCHOPNEUMONIA; CEREBROSPINAL FLUID; CHOLESTEROL BLOOD LEVEL; CONSTIPATION; CONTROLLED STUDY; CONVULSION; COUGHING; CYSTITIS; DEPRESSION; DISEASE COURSE; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; EPILEPSY; EXPANDED DISABILITY STATUS SCALE; FAINTNESS; FATIGUE; FEMALE; FEVER; FIRST DEGREE ATRIOVENTRICULAR BLOCK; HEADACHE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HERPES ZOSTER; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPOTENSION; INFLUENZA; INSOMNIA; LIVER CELL DAMAGE; LIVER DYSFUNCTION; LUNG TUMOR; LYMPHOCYTOPENIA; MACULAR EDEMA; MAJOR CLINICAL STUDY; MALE; MELANOMA; MENINGITIS; MULTICENTER STUDY; MULTIPLE SCLEROSIS; NAUSEA; NONHODGKIN LYMPHOMA; NUCLEAR MAGNETIC RESONANCE IMAGING; OVARY CANCER; PAIN; PHASE 3 CLINICAL TRIAL; PIGMENTED NEVUS; PNEUMONIA; PRESYNCOPE; PRIORITY JOURNAL; PROSTATE CANCER; PROTEIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; RETINA MACULA CYSTOID EDEMA; RHINOPHARYNGITIS; SIDE EFFECT; SPINAL CORD; SQUAMOUS CELL CARCINOMA; SYSTEMIC MYCOSIS; TINEA VERSICOLOR; TRIACYLGLYCEROL BLOOD LEVEL; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; ADOLESCENT; CLINICAL TRIAL; DOSE RESPONSE; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; ORAL DRUG ADMINISTRATION; TREATMENT OUTCOME; YOUNG ADULT;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; FINGOLIMOD HYDROCHLORIDE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84961279545     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)30083-1     Document Type: Erratum

References (30)

1. JH Noseworthy, C Lucchinetti, M Rodriguez, BG Weinshenker Multiple sclerosis N Engl J Med 343 2000 938 952
2. J Antel, S Antel, Z Caramanos, DL Arnold, T Kuhlmann Primary progressive multiple sclerosis: part of the MS disease spectrum or separate disease entity? Acta Neuropathol 123 2012 627 638
3. M Koch, E Kingwell, P Rieckmann, H Tremlett The natural history of primary progressive multiple sclerosis Neurology 73 2009 1996 2002
4. FD Lublin, SC Reingold, JA Cohen et al. Defining the clinical course of multiple sclerosis: the 2013 revisions Neurology 83 2014 278 286
5. DH Mahad, BD Trapp, H Lassmann Pathological mechanisms in progressive multiple sclerosis Lancet Neurol 14 2015 183 193
6. H Tremlett, D Paty, V Devonshire The natural history of primary progressive MS in British Columbia, Canada Neurology 65 2005 1919 1923
7. C Confavreux, S Vukusic Age at disability milestones in multiple sclerosis Brain 129 2006 595 605
8. K Hawker, P O'Connor, MS Freedman et al. Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial Ann Neurol 66 2009 460 471
9. JS Wolinsky, PA Narayana, P O'Connor et al. Glatiramer acetate in primary progressive multiple sclerosis: results of a multinational, multicenter, double-blind, placebo-controlled trial Ann Neurol 61 2007 14 24
10. JA Cohen, F Barkhof, G Comi et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis N Engl J Med 362 2010 402 415
11. PA Calabresi, EW Radue, D Goodin et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial Lancet Neurol 13 2014 545 556
12. L Kappos, EW Radue, P O'Connor et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis N Engl J Med 362 2010 387 401
13. F Barkhof, R de Jong, N Sfikas et al. The influence of patient demographics, disease characteristics and treatment on brain volume loss in Trial Assessing Injectable Interferon vs FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS), a phase 3 study of fingolimod in multiple sclerosis Mult Scler 20 2014 1704 1713
14. C Jacobsen, J Hagemeier, KM Myhr et al. Brain atrophy and disability progression in multiple sclerosis patients: a 10-year follow-up study J Neurol Neurosurg Psychiatry 85 2014 1109 1115
15. EW Radue, F Barkhof, L Kappos et al. Correlation between brain volume loss and clinical and MRI outcomes in multiple sclerosis Neurology 84 2015 784 793
16. VE Miron, SK Ludwin, PJ Darlington et al. Fingolimod (FTY720) enhances remyelination following demyelination of organotypic cerebellar slices Am J Pathol 176 2010 2682 2694
17. GM Meno-Tetang, H Li, S Mis et al. Physiologically based pharmacokinetic modeling of FTY720 (2-amino-2[2-(-4-octylphenyl)ethyl]propane-1,3-diol hydrochloride) in rats after oral and intravenous doses Drug Metab Dispos 34 2006 1480 1487
18. E Colombo, M Di Dario, E Capitolo et al. Fingolimod may support neuroprotection via blockade of astrocyte nitric oxide Ann Neurol 76 2014 325 337
19. JW Choi, SE Gardell, DR Herr et al. FTY720 (fingolimod) efficacy in an animal model of multiple sclerosis requires astrocyte sphingosine 1-phosphate receptor 1 (S1P1) modulation Proc Natl Acad Sci USA 108 2011 751 756
20. CA Foster, D Mechtcheriakova, MK Storch et al. FTY720 rescue therapy in the dark agouti rat model of experimental autoimmune encephalomyelitis: expression of central nervous system genes and reversal of blood-brain-barrier damage Brain Pathol 19 2009 254 266
21. JF Kurtzke Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS) Neurology 33 1983 1444 1452
22. HP Hartung, O Aktas Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope Ann Neurol 66 2009 429 432
23. SR Schwid, AD Goodman, MP McDermott, CF Bever, SD Cook Quantitative functional measures in MS: what is a reliable change? Neurology 58 2002 1294 1296
24. V Mathiowetz, G Volland, N Kashman, K Weber Adult norms for the Box and Block Test of manual dexterity Am J Occup Ther 39 1985 386 391
25. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH harmonised tripartite guideline. Guideline for good clinical practice: E6(R1) 1996 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, June 10 Geneva http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html (accessed Oct 5, 2014).
26. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects http://www.wma.net/en/30publications/10policies/b3/index.html (accessed Oct 5, 2014).
27. CH Polman, SC Reingold, G Edan et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria" Ann Neurol 58 2005 840 846
28. SM Smith, Y Zhang, M Jenkinson et al. Accurate, robust, and automated longitudinal and cross-sectional brain change analysis NeuroImage 17 2002 479 489
29. AM Hedman, NE van Haren, HG Schnack, RS Kahn, HE Hulshoff Pol Human brain changes across the life span: a review of 56 longitudinal magnetic resonance imaging studies Hum Brain Mapp 33 2012 1987 2002
30. M Sormani, N De Stefano, G Francis et al. Fingolimod effect on brain volume loss independently contributes to its effect on disability Mult Scler 21 2015 916 924