Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design

References

• Noseworthy JH, Lucchinetti C, Rodriguez M, et al. Multiple sclerosis. N Engl J Med 2000;343:938–52
   PubMed Web of Science ®Google Scholar
• Pike J, Jones E, Rajagopalan K, et al. Social and economic burden of walking and mobility problems in multiple sclerosis. BMC Neurol 2012;12:94
   PubMed Web of Science ®Google Scholar
• Salter AR, Cutter GR, Tyry T, et al. Impact of loss of mobility on instrumental activities of daily living and socioeconomic status in patients with MS. Curr Med Res Opin 2010;26:493-500
   PubMed Web of Science ®Google Scholar
• Dinan MA, Compton KL, Dhillon JK, et al. Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials. Med Care 2011;49:415-9
   Google Scholar
• Doward LC, McKenna SP, Meads DM, et al. The development of patient-reported outcome indices for multiple sclerosis (PRIMUS). Mult Scler 2009;15:1092-102
   PubMed Web of Science ®Google Scholar
• Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993;118:622-9
   PubMed Web of Science ®Google Scholar
• Miller D, Rudick RA, Hutchinson M. Patient-centered outcomes: translating clinical efficacy into benefits on health-related quality of life. Neurology 2010;74(3 Suppl):S24-35
   Google Scholar
• Rudick RA, Miller DM. Health-related quality of life in multiple sclerosis: current evidence, measurement and effects of disease severity and treatment. CNS Drugs 2008;22:827-39
   PubMed Web of Science ®Google Scholar
• Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362:402-15
   PubMed Web of Science ®Google Scholar
• Devonshire V, Havrdova E, Radue EW, et al. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol 2012;11:420-8
   PubMed Web of Science ®Google Scholar
• Kappos L, Radue EW, O'Connor P, et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362:387-401
   PubMed Web of Science ®Google Scholar
• Montalban X, Comi G, O'Connor P, et al. Oral fingolimod (FTY720) in relapsing multiple sclerosis: impact on health-related quality of life in a phase II study. Mult Scler 2011;17:1341-50
   PubMed Web of Science ®Google Scholar
• Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod (FTY720) treatment improves the performance of daily activities compared with intramuscular interferon β-1a: Patient-Reported Indices for Multiple Sclerosis (PRIMUS)-Activities results from a phase III study (TRANSFORMS). Presented at: American Academy of Neurology 62nd Annual Meeting; April 10-17, 2010; Toronto, Canada
   Google Scholar
• Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol 2005;58:840-6
   PubMed Web of Science ®Google Scholar
• Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes 2004;2:12
   PubMedGoogle Scholar
• Klawiter EC, Cross AH, Naismith RT. The present efficacy of multiple sclerosis therapeutics: is the new 66% just the old 33%? Neurology 2009;73:984-90
   PubMed Web of Science ®Google Scholar
• Uitdehaag BM, Barkhof F, Coyle PK, et al. The changing face of multiple sclerosis clinical trial populations. Curr Med Res Opin 2011;27:1529-37
   PubMed Web of Science ®Google Scholar
• Cunningham A, Gottberg K, von Koch L, et al. Non-adherence to interferon-beta therapy in Swedish patients with multiple sclerosis. Acta Neurol Scand 2010;121:154-60
   PubMed Web of Science ®Google Scholar
• Milanese C, Beghi E, Giordano L, et al. A post-marketing study on immunomodulating treatments for relapsing-remitting multiple sclerosis in Lombardia: preliminary results. Neurol Sci 2005;26(4 Suppl):S171-3
   Google Scholar
• Portaccio E, Zipoli V, Siracusa G, et al. Switching to second-line therapies in interferon-beta-treated relapsing-remitting multiple sclerosis patients. Eur Neurol 2009;61:177-82
   Google Scholar
• Reynolds MW, Stephen R, Seaman C, et al. Persistence and adherence to disease modifying drugs among patients with multiple sclerosis. Curr Med Res Opin 2010;26:663-74
   PubMed Web of Science ®Google Scholar
• Rio J, Porcel J, Tellez N, et al. Factors related with treatment adherence to interferon beta and glatiramer acetate therapy in multiple sclerosis. Mult Scler 2005;11:306-9
   PubMed Web of Science ®Google Scholar
• Ruggieri RM, Settipani N, Viviano L, et al. Long-term interferon-beta treatment for multiple sclerosis. Neurol Sci 2003;24:361-4
   PubMed Web of Science ®Google Scholar
• Wong J, Gomes T, Mamdani M, et al. Adherence to multiple sclerosis disease-modifying therapies in Ontario is low. Can J Neurol Sci 2011;38:429-33
   PubMed Web of Science ®Google Scholar
• Krupp LB, LaRocca NG, Muir-Nash J, et al. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989;46:1121-3
   PubMed Web of Science ®Google Scholar
• Moran PJ, Mohr DC. The validity of Beck Depression Inventory and Hamilton Rating Scale for Depression items in the assessment of depression among patients with multiple sclerosis. J Behav Med 2005;28:35-41
   PubMed Web of Science ®Google Scholar
• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976) 2000;25:3130-9
   PubMed Web of Science ®Google Scholar
• Jeffery D, Calabresi P, Goodin D, et al. Oral fingolimod (FTY720) vs placebo in relapsing-remitting multiple sclerosis (RRMS): baseline data from a 2-year phase III trial (FREEDOMS II). Presented at: The Consortium of Multiple Sclerosis Centers Annual Meeting; June 2-5, 2010; San Antonio, TX
   Google Scholar