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. 2009 Oct 7;2009(4):CD007848. doi: 10.1002/14651858.CD007848.pub2
Study Name Year Study code Reference Trial Duration in months RA disease duration in years Intervention Comparator
ABATACEPT
Moreland 2002 A0001 Moreland LW, Alten R, Van den Bosch F, Appelboom T, Leon M, Emery P, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose‐finding, double‐blind, placebo‐controlled clinical trial evaluating CTLA‐4Ig and LEA29Y eighty‐five days after the first infusion. Arthritis and Rheumatism. 2002 Jun;46(6):1470‐9. 3 3.3 ABA PL
Genovese 2005 A0002 Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. New England Journal of Medicine. 2005 Sep 15;353(11):1114‐23 6 11.9 ABA + DMARD DMARD + PL
Schiff 2008 A0003 Schiff MH, Pritchard C, Huffstutter JE, Rodriguez‐Valverde V, Durez P, Zhou X, et al. The 6‐month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti‐TNF therapy or were directly switched to abatacept: the ARRIVE trial. Annals of the Rheumatic Diseases. 2008 Dec 15. 6 8.1 ABA + MTX MTX + PL
Kremer 2003 A0004 Kremer JM, Westhovens R, Leon M, Di Giorgio E, Alten R, Steinfeld S, et al. Treatment of rheumatoid arthritis by selective inhibition of T‐cell activation with fusion protein CTLA4Ig. New England Journal of Medicine. 2003 Nov 13;349(20):1907‐15. 6 9.2 ABA + MTX MTX + PL
Kremer 2006 A0005 Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud‐Mendoza C, et al. Effects of abatacept in patients with methotrexate‐resistant active rheumatoid arthritis: a randomized trial. Annals of Internal Medicine. 2006 Jun 20;144(12):865‐76. 12 8.6 ABA + MTX MTX + PL
Weinblatt 2007 A0006 Weinblatt M, Schiff M, Goldman A, Kremer J, Luggen M, Li T, et al. Selective costimulation modulation using abatacept in patients with active rheumatoid arthritis while receiving etanercept: a randomised clinical trial. Annals of the Rheumatic Diseases. 2007 Feb;66(2):228‐34. 12 12.9 ABA + ETN ETN + PL
Weinblatt (ASSURE) 2006 A0007 Weinblatt M, Combe B, Covucci A, Aranda R, Becker JC, Keystone E. Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease‐modifying antirheumatic drugs: A one‐year randomized, placebo‐controlled study. Arthritis Rheum. 2006 Sep;54(9):2807‐16.. 12 9.7 ABA + DMARD(biologic + non‐biologic) DMARD(biologic + non‐biologic) + PL
ADALIMUMAB
Bejarano 2008 A0008 Bejarano V, Quinn M, Conaghan PG, Reece R, Keenan AM, Walker D, et al. Effect of the early use of the anti‐tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritis. Arthritis and Rheumatism. 2008 Oct 15;59(10):1467‐74. 13 0.9 ADA + MTX MTX + PL
Breedveld 2006 A0009 Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, 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 and Rheumatism. 2006 Jan;54(1):26‐37. 24 0.7 ADA + MTX MTX + PL
Furst 2003 A0010 Furst DE, Schiff MH, Fleischmann RM, Strand V, Birbara CA, Compagnone D, 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). The Journal of Rheumatology. 2003 Dec;30(12):2563‐71. 6 10.4 ADA + DMARD DMARD + PL
Keystone 2004 A0011 Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, 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 and Rheumatism. 2004 May;50(5):1400‐11. 12 11.0 ADA + MTX MTX + PL
Kim 2007 A0012 Kim H, Lee S, Song Y, Yoo D, Koh EM, Yoo B, et al. A randomized, double‐blind, placebo‐controlled, phase III study of the human anti‐tumor necrosis factor antibody adalimumab administered as subcutaneous injections in Korean rheumatoid arthritis patients treated with methotrexate. APLAR Journal of Rheumatology. 2007;10:9‐16. 6 6.8 ADA + MTX MTX + PL
Miyasaka 2008 A0013 Miyasaka N. Clinical investigation in highly disease‐affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE study. Modern Rheumatology. 2008;18(3):252‐62. 6 9.8 ADA PL
Van de Putte 2004 A0014 van de Putte LB, Atkins C, Malaise M, Sany J, Russell AS, van Riel PL, et al. Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed. Annals of the Rheumatic Diseases. 2004 May;63(5):508‐16. 6 11.1 ADA PL
Weinblatt 2003 A0015 Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, 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 and Rheumatism. 2003 Jan;48(1):35‐45. 6 11.7 ADA + MTX MTX + PL
ANAKINRA
Bresnihan 1998 A0016 Bresnihan B, Alvaro‐Gracia JM, Cobby M, Doherty M, Domljan Z, Emery P, et al. Treatment of rheumatoid arthritis with recombinant human interleukin‐1 receptor antagonist. Arthritis and Rheumatism. 1998 Dec;41(12):2196‐204. 6 4.1 ANA PL
Fleischiman 2003 A0017 Fleischmann RM, Schechtman J, Bennett R, Handel ML, Burmester GR, Tesser J, et al. Anakinra, a recombinant human interleukin‐1 receptor antagonist (r‐metHuIL‐1ra), in patients with rheumatoid arthritis: A large, international, multicenter, placebo‐controlled trial. Arthritis and Rheumatism. 2003 Apr;48(4):927‐34. 6 10.3 ANA + DMARD PL + DMARD
Cohen 2002 A0018 Cohen S, Hurd E, Cush J, Schiff M, Weinblatt ME, Moreland LW, et al. Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin‐1 receptor antagonist, in combination with methotrexate: results of a twenty‐four‐week, multicenter, randomized, double‐blind, placebo‐controlled trial. Arthritis and Rheumatism. 2002 Mar;46(3):614‐24. 6 7.8 ANA + MTX MTX + PL
Cohen 2004 A0019 Cohen SB, Moreland LW, Cush JJ, Greenwald MW, Block S, Shergy WJ, et al. A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Annals of the Rheumatic Diseases. 2004 Sep;63(9):1062‐8. 6 10.5 ANA + MTX MTX + PL
Genovese 2004 A0020 Genovese MC, Cohen S, Moreland L, Lium D, Robbins S, Newmark R, et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis and Rheumatism. 2004 May;50(5):1412‐9. 6 10.2 ANA + ETN +MTX ETN + MTX + PL
ETANERCEPT
Moreland 1999 A0021 Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Annals of Internal Medicine. 1999 Mar 16;130(6):478‐86. 6 11.5 ETA PL
Weinblatt 1999 A0022 Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. New England Journal of Medicine. 1999 Jan 28;340(4):253‐9. 6 13.0 ETA + MTX MTX + PL
Emery (COMET) 2008 A0023 Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, 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 Feb 28;363(9410):675‐81. 12 0.9 ETA + MTX MTX + PL
Klareskog (TEMPO) 2004 A0024 Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double‐blind, parallel treatment trial. Lancet. 2008 Aug 2;372(9636):375‐82. 12 6.8 ETA + MTX MTX + PL
INFLIXIMAB
Maini 1998 A0025 Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, et al. Therapeutic efficacy of multiple intravenous infusions of anti‐tumor necrosis factor alpha monoclonal antibody combined with low‐dose weekly methotrexate in rheumatoid arthritis. Arthritis and Rheumatism. 1998 Sep;41(9):1552‐63. 6 9.9 INF + MTX MTX + PL
St. Clair (ASPIRE) 2004 A0026 St Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis and Rheumatism. 2004 Nov;50(11):3432‐43. 12 0.8 INF + MTX MTX + PL
Lipsky (ATTRACT) 2000 A0027 Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti‐Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. New England Journal of Medicine. 2000 Nov 30;343(22):1594‐602. 12 10.5 INF + MTX MTX + PL
Quinn 2005 A0028 Quinn MA, Conaghan PG, O'Connor PJ, Karim Z, Greenstein A, Brown A, 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 and Rheumatism. 2005 Jan;52(1):27‐35. 12 0.7 INF + MTX MTX + PL
               
RITUXIMAB            
Edwards 2004 A0029 Edwards JC, Szczepanski L, Szechinski J, Filipowicz‐Sosnowska A, Emery P, Close DR, et al. Efficacy of B‐cell‐targeted therapy with rituximab in patients with rheumatoid arthritis. New England Journal of Medicine. 2004 Jun 17;350(25):2572‐81. 6 11.5 RIT + MTX MTX + PL
Emery (DANCER) 2006 A0030 Emery P, Fleischmann R, Filipowicz‐Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double‐blind, placebo‐controlled, dose‐ranging trial. Arthritis and Rheumatism. 2006 May;54(5):1390‐400. 6 10.1 RIT + MTX MTX + PL
Cohen (REFLEX) 2006 A0031 Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti‐tumor necrosis factor therapy: Results of a multicenter, randomized, double‐blind, placebo‐controlled, phase III trial evaluating primary efficacy and safety at twenty‐four weeks. Arthritis and Rheumatism. 2006 Sep;54(9):2793‐806. 6 11.9 RIT + MTX MTX + PL