메뉴 건너뛰기




Volumn 47, Issue 7, 2008, Pages 1054-1057

Most tumour necrosis factor inhibitor trials in rheumatology are undeservedly called 'efficacy and safety' trials: A survey of power considerations

Author keywords

Harm; Power calculation; Randomized clinical trial; Tumour necrosis factor inhibitors; Type II error

Indexed keywords

ADALIMUMAB; ETANERCEPT; INFLIXIMAB; TUMOR NECROSIS FACTOR ANTIBODY;

EID: 45749083372     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ken190     Document Type: Article
Times cited : (16)

References (40)
  • 1
    • 17044362679 scopus 로고    scopus 로고
    • Sample size calculations in randomized trials: Mandatory and mystical
    • Schulz KF, Grimes DA. Sample size calculations in randomized trials: mandatory and mystical. Lancet 2005;365:1346-53.
    • (2005) Lancet , vol.365 , pp. 1346-1353
    • Schulz, K.F.1    Grimes, D.A.2
  • 2
    • 85136357727 scopus 로고    scopus 로고
    • Piaggio G, Elbourne DR. Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. J Am Med Assoc 2006;295:1152-60.
    • Piaggio G, Elbourne DR. Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. J Am Med Assoc 2006;295:1152-60.
  • 3
    • 0028143211 scopus 로고
    • Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis
    • Elliott MJ, Maini RN, Feldmann M et al. Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis. Lancet 1994;344:1105-10.
    • (1994) Lancet , vol.344 , pp. 1105-1110
    • Elliott, M.J.1    Maini, R.N.2    Feldmann, M.3
  • 4
    • 0033524159 scopus 로고    scopus 로고
    • Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomised phase III trial
    • Maini R, St Clair EW, Breedveld F et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: A randomised phase III trial. Lancet 1999;354:1932-9.
    • (1999) Lancet , vol.354 , pp. 1932-1939
    • Maini, R.1    St Clair, E.W.2    Breedveld, F.3
  • 5
    • 0033574147 scopus 로고    scopus 로고
    • Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial
    • Moreland LW, Schiff MH, Baumgartner SW et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Mad 1999;130:478-86.
    • (1999) Ann Intern Mad , vol.130 , pp. 478-486
    • Moreland, L.W.1    Schiff, M.H.2    Baumgartner, S.W.3
  • 6
    • 0033611472 scopus 로고    scopus 로고
    • A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate
    • Weinblatt ME, Kremer JM, Bankhurst AD et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999;340:253-9.
    • (1999) N Engl J Med , vol.340 , pp. 253-259
    • Weinblatt, M.E.1    Kremer, J.M.2    Bankhurst, A.D.3
  • 7
    • 0034735827 scopus 로고    scopus 로고
    • A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis
    • Bathon JM, Martin RW, Fleischmann RM et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93.
    • (2000) N Engl J Med , vol.343 , pp. 1586-1593
    • Bathon, J.M.1    Martin, R.W.2    Fleischmann, R.M.3
  • 8
    • 0034729950 scopus 로고    scopus 로고
    • Etanercept in the treatment of psoriatic arthritis and psoriasis: A randomised trial
    • Mease PJ, Goffe BS, Metz J et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: A randomised trial. Lancet 2000;356:385-90.
    • (2000) Lancet , vol.356 , pp. 385-390
    • Mease, P.J.1    Goffe, B.S.2    Metz, J.3
  • 9
    • 0037029430 scopus 로고    scopus 로고
    • Treatment of active ankylosing spondylitis with infliximab: A randomised controlled multicentre trial
    • Braun J, Brandt J, Listing J et al. Treatment of active ankylosing spondylitis with infliximab: A randomised controlled multicentre trial. Lancet 2002;359:1187-93.
    • (2002) Lancet , vol.359 , pp. 1187-1193
    • Braun, J.1    Brandt, J.2    Listing, J.3
  • 10
    • 0037007683 scopus 로고    scopus 로고
    • Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha
    • Gorman JD, Sack KE, Davis JC Jr. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med. 2002;346:1349-56.
    • (2002) N Engl J Med , vol.346 , pp. 1349-1356
    • Gorman, J.D.1    Sack, K.E.2    Davis Jr., J.C.3
  • 11
    • 0037783485 scopus 로고    scopus 로고
    • Six-month results of a double-blind, placebo-controlled trial of etanercept treatment in patients with active ankylasing spandylitis
    • Brandt J, Khariouzov A, Listing J et al. Six-month results of a double-blind, placebo-controlled trial of etanercept treatment in patients with active ankylasing spandylitis. Arthritis Rheum 2003;48:1667-75.
    • (2003) Arthritis Rheum , vol.48 , pp. 1667-1675
    • Brandt, J.1    Khariouzov, A.2    Listing, J.3
  • 12
    • 0242411795 scopus 로고    scopus 로고
    • Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: A randomized, controlled trial
    • Davis JC Jr, Van Der Heijde D, Braun J et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: A randomized, controlled trial. Arthritis Rheum 2003;48:3230-6.
    • (2003) Arthritis Rheum , vol.48 , pp. 3230-3236
    • Davis Jr, J.C.1    Van Der Heijde, D.2    Braun, J.3
  • 13
    • 0348109372 scopus 로고    scopus 로고
    • Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: Results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis)
    • Furst DE, Schiff MH, Fleischmann RM et al. Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: Results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 2003;30:2563-71.
    • (2003) J Rheumatol , vol.30 , pp. 2563-2571
    • Furst, D.E.1    Schiff, M.H.2    Fleischmann, R.M.3
  • 14
    • 10744227300 scopus 로고    scopus 로고
    • Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: A 12 week, phase II study
    • van de Putte LB, Rau R, Breedveld FC et al. Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: A 12 week, phase II study. Ann Rheum Dis 2003;62:1168-77.
    • (2003) Ann Rheum Dis , vol.62 , pp. 1168-1177
    • van de Putte, L.B.1    Rau, R.2    Breedveld, F.C.3
  • 15
    • 0037231533 scopus 로고    scopus 로고
    • Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial
    • Weinblatt ME, Keystone EC, Furst DE et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial. Arthritis Rheum 2003;48:35-45.
    • (2003) Arthritis Rheum , vol.48 , pp. 35-45
    • Weinblatt, M.E.1    Keystone, E.C.2    Furst, D.E.3
  • 16
    • 9644266805 scopus 로고    scopus 로고
    • Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis
    • Calin A, Dijkmans BA, Emery P et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis 2004;63:1594-600.
    • (2004) Ann Rheum Dis , vol.63 , pp. 1594-1600
    • Calin, A.1    Dijkmans, B.A.2    Emery, P.3
  • 17
    • 4344578260 scopus 로고    scopus 로고
    • A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment
    • Durez P, Nzeusseu Toukap A, Lauwerys BR et al. A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment. Ann Rheum Dis 2004;63:1069-74.
    • (2004) Ann Rheum Dis , vol.63 , pp. 1069-1074
    • Durez, P.1    Nzeusseu Toukap, A.2    Lauwerys, B.R.3
  • 18
    • 2342551979 scopus 로고    scopus 로고
    • Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotraxate
    • Genovese MC, Cohen S, Moreland L et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotraxate. Arthritis Rheum 2004;50:1412-9.
    • (2004) Arthritis Rheum , vol.50 , pp. 1412-1419
    • Genovese, M.C.1    Cohen, S.2    Moreland, L.3
  • 19
    • 2342658406 scopus 로고    scopus 로고
    • Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: A randomized, placebo-controlled, 52-week trial
    • Keystone EC, Kavanaugh AF, Sharp JT et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: A randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
    • (2004) Arthritis Rheum , vol.50 , pp. 1400-1411
    • Keystone, E.C.1    Kavanaugh, A.F.2    Sharp, J.T.3
  • 20
    • 1042290332 scopus 로고    scopus 로고
    • Once-weekly administration of 50mg etanercept in patients with active rheumatoid arthritis: Results of a multicenter, randomized, double-blind, placebo-controlled trial
    • Keystone EC, Schiff MH, Kremer JM et al. Once-weekly administration of 50mg etanercept in patients with active rheumatoid arthritis: Results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:353-63.
    • (2004) Arthritis Rheum , vol.50 , pp. 353-363
    • Keystone, E.C.1    Schiff, M.H.2    Kremer, J.M.3
  • 21
    • 10744223002 scopus 로고    scopus 로고
    • Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: Double-blind randomised controlled trial
    • Klareskog L, van der Heijde D, de Jager JP et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: Double-blind randomised controlled trial. Lancet 2004;363:675-81.
    • (2004) Lancet , vol.363 , pp. 675-681
    • Klareskog, L.1    van der Heijde, D.2    de Jager, J.P.3
  • 22
    • 11144354315 scopus 로고    scopus 로고
    • Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate
    • Maini FIN, Breedveld FC, Kalden JR et al. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum 2004;50:1051-65.
    • (2004) Arthritis Rheum , vol.50 , pp. 1051-1065
    • Maini, F.I.N.1    Breedveld, F.C.2    Kalden, J.R.3
  • 23
    • 3042649266 scopus 로고    scopus 로고
    • Etanercept treatment of psoriatic arthritis: Safety, efficacy, and effect on disease progression
    • Meese PJ, Kivitz AJ, Burch FX et al. Etanercept treatment of psoriatic arthritis: Safety, efficacy, and effect on disease progression. Arthritis Rheum 2004; 50;2264-72.
    • (2004) Arthritis Rheum , vol.50 , pp. 2264-2272
    • Meese, P.J.1    Kivitz, A.J.2    Burch, F.X.3
  • 24
    • 8444239359 scopus 로고    scopus 로고
    • Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: A randomized, controlled trial
    • St Clair EW, van der Heijde DM, Smolen JS et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: A randomized, controlled trial. Arthritis Rheum 2004;50:3432-43.
    • (2004) Arthritis Rheum , vol.50 , pp. 3432-3443
    • St Clair, E.W.1    van der Heijde, D.M.2    Smolen, J.S.3
  • 25
    • 11144355274 scopus 로고    scopus 로고
    • Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed
    • van de Putte LB, Atkins C, Malaise M et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Ann Rheum Dis 2004;63:508-16.
    • (2004) Ann Rheum Dis , vol.63 , pp. 508-516
    • van de Putte, L.B.1    Atkins, C.2    Malaise, M.3
  • 26
    • 20244376625 scopus 로고    scopus 로고
    • Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: Results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT)
    • Antoni CE, Kavanaugh A, Kirkham B et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: Results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum 2005;52:1227-36.
    • (2005) Arthritis Rheum , vol.52 , pp. 1227-1236
    • Antoni, C.E.1    Kavanaugh, A.2    Kirkham, B.3
  • 27
    • 19044382942 scopus 로고    scopus 로고
    • Infliximab improves signs and symptoms of psoriatic arthritis: Results of the IMPACT 2 trial
    • Antoni C, Krueger GG, de Vlam K et al. Infliximab improves signs and symptoms of psoriatic arthritis: Results of the IMPACT 2 trial. Ann Rheum Dis 2005;64:1150-7.
    • (2005) Ann Rheum Dis , vol.64 , pp. 1150-1157
    • Antoni, C.1    Krueger, G.G.2    de Vlam, K.3
  • 28
    • 13444253765 scopus 로고    scopus 로고
    • Efficacy and safety of infliximab in patients with ankylosing spondylitis: Results of a randomized, placebo-controlled trial (ASSERT)
    • van der Haijde D, Dijkmans B, Geusens P et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: Results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005;52:582-91.
    • (2005) Arthritis Rheum , vol.52 , pp. 582-591
    • van der Haijde, D.1    Dijkmans, B.2    Geusens, P.3
  • 29
    • 26844432745 scopus 로고    scopus 로고
    • Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double-blind, randomized, placebo-controlled trial
    • Meese PJ, Gladman DD, Ritchlin CT et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:3279-89.
    • (2005) Arthritis Rheum , vol.52 , pp. 3279-3289
    • Meese, P.J.1    Gladman, D.D.2    Ritchlin, C.T.3
  • 30
    • 19944431840 scopus 로고    scopus 로고
    • Very early treatment with infliximab in addition to methotrexate in early, poor-prognosis rheumatoid arthritis reduces magnetic resonance imaging evidence of synovitis and damage, with sustained benefit after infliximab withdrawal: Results from a twelve-month randomized, double-blind, placebo-controlled trial
    • Quinn MA, Conaghan PG, O'Connor PJ et al. Very early treatment with infliximab in addition to methotrexate in early, poor-prognosis rheumatoid arthritis reduces magnetic resonance imaging evidence of synovitis and damage, with sustained benefit after infliximab withdrawal: Results from a twelve-month randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2005;52:27-35.
    • (2005) Arthritis Rheum , vol.52 , pp. 27-35
    • Quinn, M.A.1    Conaghan, P.G.2    O'Connor, P.J.3
  • 31
    • 30144442293 scopus 로고    scopus 로고
    • A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis
    • Abe T, Takeuchi T, Miyasaka N et al. A multicenter, double-blind, randomized, placebo controlled trial of infliximab combined with low dose methotrexate in Japanese patients with rheumatoid arthritis. J Rheumatol 2006;33:37-44.
    • (2006) J Rheumatol , vol.33 , pp. 37-44
    • Abe, T.1    Takeuchi, T.2    Miyasaka, N.3
  • 32
    • 31044442965 scopus 로고    scopus 로고
    • The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment
    • Breadveld FC, Weisman MH, Kavanaugh AF et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006;54:26-37.
    • (2006) Arthritis Rheum , vol.54 , pp. 26-37
    • Breadveld, F.C.1    Weisman, M.H.2    Kavanaugh, A.F.3
  • 33
    • 33750372498 scopus 로고    scopus 로고
    • Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: A double-blind comparison
    • Combe B, Codreanu C, Fiocco U et al. Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: A double-blind comparison. Ann Rheum Dis 2006;65:1357-62.
    • (2006) Ann Rheum Dis , vol.65 , pp. 1357-1362
    • Combe, B.1    Codreanu, C.2    Fiocco, U.3
  • 34
    • 33751302864 scopus 로고    scopus 로고
    • Etanercept 50 mg once weekly is as effective as 25mg twice weekly in patients with ankylosing spondylitis
    • van der Heijde D, Da Silva JC, Dougados M et al. Etanercept 50 mg once weekly is as effective as 25mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis 2006;65:1572-7.
    • (2006) Ann Rheum Dis , vol.65 , pp. 1572-1577
    • van der Heijde, D.1    Da Silva, J.C.2    Dougados, M.3
  • 35
    • 33745894976 scopus 로고    scopus 로고
    • Efficacy and safety of adalimumab in patients with ankylosing spondylitis: Results of a multicenter, randomized, double-blind, placebo-controlled trial
    • van der Heijde D, Kivitz A, Schiff MH et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: Results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2006;54:2136-46.
    • (2006) Arthritis Rheum , vol.54 , pp. 2136-2146
    • van der Heijde, D.1    Kivitz, A.2    Schiff, M.H.3
  • 36
    • 33646379583 scopus 로고    scopus 로고
    • The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: A large, randomized, placebo-controlled trial
    • Westhovens R, Yocum D, Han J et al. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: A large, randomized, placebo-controlled trial. Arthritis Rheum 2006;54:1075-86.
    • (2006) Arthritis Rheum , vol.54 , pp. 1075-1086
    • Westhovens, R.1    Yocum, D.2    Han, J.3
  • 37
    • 24944462912 scopus 로고    scopus 로고
    • Inclusion criteria as widely used for rheumatoid arthritis clinical trials
    • Patent eligibility in a Turkish cohort. Clin Exp Rheumatol 2005; 23:681-4
    • Gogus F, Yazici Y, Yazici H. Inclusion criteria as widely used for rheumatoid arthritis clinical trials: Patent eligibility in a Turkish cohort. Clin Exp Rheumatol 2005; 23:681-4.
    • Gogus, F.1    Yazici, Y.2    Yazici, H.3
  • 38
    • 0038724287 scopus 로고    scopus 로고
    • Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or american College of rheumatology criteria for remission
    • Sokka T, Pincus T. Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or american College of rheumatology criteria for remission. J Rheumatol 2003;30:1138-46.
    • (2003) J Rheumatol , vol.30 , pp. 1138-1146
    • Sokka, T.1    Pincus, T.2
  • 39
    • 33748444790 scopus 로고    scopus 로고
    • Problems encountered during anti-tumour necrosis factor therapy
    • Desal SB, Furst DE. Problems encountered during anti-tumour necrosis factor therapy. Best Pract Res Clin Rheumatol 2006;20:757-90.
    • (2006) Best Pract Res Clin Rheumatol , vol.20 , pp. 757-790
    • Desal, S.B.1    Furst, D.E.2
  • 40
    • 4644292825 scopus 로고    scopus 로고
    • Misinterpretation of numbers: A potential source of physician error
    • Ghosh AK, Ghosh K. Misinterpretation of numbers: A potential source of physician error. Lancet 2004;364:1108-10.
    • (2004) Lancet , vol.364 , pp. 1108-1110
    • Ghosh, A.K.1    Ghosh, K.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.