Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): A phase 3 randomised trial

The Lancet Neurology

Volumn 13, Issue 3, 2014, Pages 257-267

  Leist, Thomas P ^a   Comi, Giancarlo ^b   Cree, Bruce A C ^c   Coyle, Patricia K ^d   Freedman, Mark S ^e   Hartung, Hans Peter ^f   Vermersch, Patrick ^g   Casset Semanaz, Florence ^h   Scaramozza, Matthew ^h  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b SAN RAFFAELE HOSPITAL   (Italy)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d STONY BROOK UNIVERSITY MEDICAL CENTER   (United States)

^e OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^f Department of Orthopedic Surgery   (Germany)

^g UNIV LILLE   (France)

^h EMD SERONO INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; CLADRIBINE; DEMYELINATING DISEASES; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; MULTIPLE SCLEROSIS; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84894261465     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(14)70005-5     Document Type: Article

References (17)

1. Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 2011, 69:292-302.
2. Comi G, Filippi M, Barkhof F, et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet 2001, 357:1576-1582.
3. Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet 2009, 374:1503-1511.
4. Comi G, De Stefano N, Freedman MS, et al. Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial. Lancet Neurol 2012, 11:33-41.
5. Jacobs LD, Beck RW, Simon JH, et al. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group. N Engl J Med 2000, 343:898-904.
6. Kappos L, Freedman MS, Polman CH, et al. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet 2007, 370:389-397.
7. Chitnis T The role of CD4 T cells in the pathogenesis of multiple sclerosis. Int Rev Neurobiol 2007, 79:43-72.
8. Franciotta D, Salvetti M, Lolli F, Serafini B, Aloisi F B cells and multiple sclerosis. Lancet Neurol 2008, 7:852-858.
9. Kleinschnitz C, Meuth SG, Kieseier BC, Wiendl H Immunotherapeutic approaches in MS: update on pathophysiology and emerging agents or strategies 2006. Endocr Metab Immune Disord Drug Targets 2007, 7:35-63.
10. Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med 2010, 362:416-426.
11. Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol 2005, 58:840-846.
12. Poser CM, Paty DW, Scheinberg L, et al. New diagnostic criteria for multiple sclerosis: guidelines for research protocols. Ann Neurol 1983, 13:227-231.
13. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology 2006, 67:1242-1249.
14. Leist TP, Weissert R Cladribine: mode of action and implications for treatment of multiple sclerosis. Clin Neuropharmacol 2011, 34:28-35.
15. Selby MJ, Ling N, Williams JM, Dawson A Interferon beta 1-b in verbal memory functioning of patients with relapsing-remitting multiple sclerosis. Percept Mot Skills 1998, 86:1099-1106.
16. El Kebir S Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials (PREMIERE). ClinicalTrials gov 2013 (accessed July 4, 2013). http://www.clinicaltrials.gov/ct2/show/NCT01013350.
17. Clerico M, Faggiano F, Palace J, Rice G, Tintore M, Durelli L Recombinant interferon beta or glatiramer acetate for delaying conversion of the first demyelinating event to multiple sclerosis. Cochrane Database Syst Rev 2008, 16. CD005278.