메뉴 건너뛰기




Volumn 13, Issue 10, 2014, Pages 977-986

Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): A randomised, double-blind, placebo-controlled, phase 3 trial

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; PLACEBO; TERIFLUNOMIDE; ASPARTATE AMINOTRANSFERASE; CROTONIC ACID DERIVATIVE; IMMUNOLOGIC FACTOR; TOLUIDINE DERIVATIVE;

EID: 84907963174     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(14)70191-7     Document Type: Article
Times cited : (264)

References (25)
  • 2
    • 78751613188 scopus 로고    scopus 로고
    • Treatment effects of immunomodulatory therapies at different stages of multiple sclerosis in short-term trials
    • Bates D Treatment effects of immunomodulatory therapies at different stages of multiple sclerosis in short-term trials. Neurology 2011, 76(1 suppl):S14-S25.
    • (2011) Neurology , vol.76 , Issue.1 , pp. S14-S25
    • Bates, D.1
  • 3
    • 0034727059 scopus 로고    scopus 로고
    • Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group
    • 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.
    • (2000) N Engl J Med , vol.343 , pp. 898-904
    • Jacobs, L.D.1    Beck, R.W.2    Simon, J.H.3
  • 4
    • 0035912520 scopus 로고    scopus 로고
    • Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study
    • 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.
    • (2001) Lancet , vol.357 , pp. 1576-1582
    • Comi, G.1    Filippi, M.2    Barkhof, F.3
  • 5
    • 6944246720 scopus 로고    scopus 로고
    • Interferon beta-1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial
    • Filippi M, Rovaris M, Inglese M, et al. Interferon beta-1a for brain tissue loss in patients at presentation with syndromes suggestive of multiple sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet 2004, 364:1489-1496.
    • (2004) Lancet , vol.364 , pp. 1489-1496
    • Filippi, M.1    Rovaris, M.2    Inglese, M.3
  • 6
    • 33749661011 scopus 로고    scopus 로고
    • Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes
    • 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.
    • (2006) Neurology , vol.67 , pp. 1242-1249
    • Kappos, L.1    Polman, C.H.2    Freedman, M.S.3
  • 7
    • 83555166210 scopus 로고    scopus 로고
    • 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
    • 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, 10:33-41.
    • (2012) Lancet Neurol , vol.10 , pp. 33-41
    • Comi, G.1    De Stefano, N.2    Freedman, M.S.3
  • 8
    • 70350786389 scopus 로고    scopus 로고
    • 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
    • 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.
    • (2009) Lancet , vol.374 , pp. 1503-1511
    • Comi, G.1    Martinelli, V.2    Rodegher, M.3
  • 9
    • 84894261465 scopus 로고    scopus 로고
    • 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
    • Leist TP, Comi G, Cree BA, et al. 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. Lancet Neurol 2014, 13:25-67.
    • (2014) Lancet Neurol , vol.13 , pp. 25-67
    • Leist, T.P.1    Comi, G.2    Cree, B.A.3
  • 10
    • 33645100122 scopus 로고    scopus 로고
    • IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event
    • Kinkel RP, Kollman C, O'Connor P, et al. IM interferon beta-1a delays definite multiple sclerosis 5 years after a first demyelinating event. Neurology 2006, 66:678-684.
    • (2006) Neurology , vol.66 , pp. 678-684
    • Kinkel, R.P.1    Kollman, C.2    O'Connor, P.3
  • 11
    • 84856878936 scopus 로고    scopus 로고
    • Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance
    • Kinkel RP, Dontchev M, Kollman C, et al. Association between immediate initiation of intramuscular interferon beta-1a at the time of a clinically isolated syndrome and long-term outcomes: a 10-year follow-up of the Controlled High-Risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance. Arch Neurol 2012, 69:183-190.
    • (2012) Arch Neurol , vol.69 , pp. 183-190
    • Kinkel, R.P.1    Dontchev, M.2    Kollman, C.3
  • 12
    • 34547497820 scopus 로고    scopus 로고
    • 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
    • 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.
    • (2007) Lancet , vol.370 , pp. 389-397
    • Kappos, L.1    Freedman, M.S.2    Polman, C.H.3
  • 13
    • 70449713830 scopus 로고    scopus 로고
    • Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial
    • Kappos L, Freedman MS, Polman CH, et al. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol 2009, 8:987-997.
    • (2009) Lancet Neurol , vol.8 , pp. 987-997
    • Kappos, L.1    Freedman, M.S.2    Polman, C.H.3
  • 14
    • 84879752237 scopus 로고    scopus 로고
    • Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome
    • Comi G, Martinelli V, Rodegher M, et al. Effects of early treatment with glatiramer acetate in patients with clinically isolated syndrome. Mult Scler 2013, 19:1074-1083.
    • (2013) Mult Scler , vol.19 , pp. 1074-1083
    • Comi, G.1    Martinelli, V.2    Rodegher, M.3
  • 15
    • 84899856893 scopus 로고    scopus 로고
    • Teriflunomide and its mechanism of action in multiple sclerosis
    • Bar-Or A, Pachner A, Menguy-Vacheron F, et al. Teriflunomide and its mechanism of action in multiple sclerosis. Drugs 2014, 74:659-674.
    • (2014) Drugs , vol.74 , pp. 659-674
    • Bar-Or, A.1    Pachner, A.2    Menguy-Vacheron, F.3
  • 16
    • 80053533877 scopus 로고    scopus 로고
    • Randomized trial of oral teriflunomide for relapsing multiple sclerosis
    • O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011, 365:1293-1303.
    • (2011) N Engl J Med , vol.365 , pp. 1293-1303
    • O'Connor, P.1    Wolinsky, J.S.2    Confavreux, C.3
  • 17
    • 84894271594 scopus 로고    scopus 로고
    • Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial
    • Confavreux C, O'Connor P, Comi G, et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol 2014, 13:247-256.
    • (2014) Lancet Neurol , vol.13 , pp. 247-256
    • Confavreux, C.1    O'Connor, P.2    Comi, G.3
  • 18
    • 84883410242 scopus 로고    scopus 로고
    • Magnetic resonance imaging outcomes from a phase III trial of teriflunomide
    • Wolinsky JS, Narayana PA, Nelson F, et al. Magnetic resonance imaging outcomes from a phase III trial of teriflunomide. Mult Scler J 2013, 19:1310-1319.
    • (2013) Mult Scler J , vol.19 , pp. 1310-1319
    • Wolinsky, J.S.1    Narayana, P.A.2    Nelson, F.3
  • 19
    • 85081844058 scopus 로고    scopus 로고
    • International Conference on Harmonisation Expert Working Group, (accessed March 11, 2014).
    • ICH harmonised tripartite guideline-guideline for good clinical practice E6(R1) International Conference on Harmonisation Expert Working Group, (accessed March 11, 2014). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf.
    • ICH harmonised tripartite guideline-guideline for good clinical practice E6(R1)
  • 21
    • 79952501096 scopus 로고    scopus 로고
    • Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald Criteria
    • 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.
    • (2011) Ann Neurol , vol.69 , pp. 292-302
    • Polman, C.H.1    Reingold, S.C.2    Banwell, B.3
  • 22
    • 28544436950 scopus 로고    scopus 로고
    • Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria"
    • 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.
    • (2005) Ann Neurol , vol.58 , pp. 840-846
    • Polman, C.H.1    Reingold, S.C.2    Edan, G.3
  • 23
    • 12344312699 scopus 로고    scopus 로고
    • Cancer Therapy Evaluation Program, (accessed March 11, 2014).
    • Common Terminology Criteria for Adverse Events v 3.0 Cancer Therapy Evaluation Program, (accessed March 11, 2014). http://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf.
    • Common Terminology Criteria for Adverse Events v 3.0
  • 24
    • 84860199056 scopus 로고    scopus 로고
    • Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years
    • Confavreux C, Li DK, Freedman MS, et al. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler 2012, 18:1278-1289.
    • (2012) Mult Scler , vol.18 , pp. 1278-1289
    • Confavreux, C.1    Li, D.K.2    Freedman, M.S.3
  • 25
    • 84897022266 scopus 로고    scopus 로고
    • Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial
    • Vermersch P, Czlonkowska A, Grimaldi LME, et al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler 2013, 20:705-716.
    • (2013) Mult Scler , vol.20 , pp. 705-716
    • Vermersch, P.1    Czlonkowska, A.2    Grimaldi, L.M.E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.