title: Design of the tocilizumab in giant cell arteritis trial.
abstract: Overview. The GiACTA trial is a multicenter, randomized, double-blind, and placebo-controlled study designed to test the ability of tocilizumab (TCZ), an interleukin (IL)-6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis (GCA). Design. Approximately 100 centers will enroll 250 patients with active disease. The trial consists of a 52-week blinded treatment phase followed by 104 weeks of open-label extension. Patients will be randomized into one of four groups. Group A (TCZ 162 mg weekly plus a 6-month prednisone-taper); group B (TCZ 162 mg every other week plus a 6-month prednisone-taper); group C (placebo plus a 6-month prednisone-taper); and group D (placebo plus a 12-month prednisone taper). We hypothesize that patients assigned to TCZ in addition to a 6-month prednisone course are more likely to achieve the primary efficacy endpoint of sustained remission (SR) at 52 weeks compared with those assigned to a 6-month prednisone course alone, thus potentially minimizing the long-term adverse effects of corticosteroids. Conclusion. GiACTA will test the hypothesis that interference with IL-6 signaling exerts a beneficial effect on patients with GCA. The objective of this paper is to describe the design of the trial and address major issues related to its development.
authors: Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
authors: Sebastian H
authors: SH
authors: Unizony
authors: Bhaskar
authors: B
authors: Dasgupta
authors: Elena
authors: E
authors: Fisheleva
authors: Lucy
authors: L
authors: Rowell
authors: Georg
authors: G
authors: Schett
authors: Robert
authors: R
authors: Spiera
authors: Jochen
authors: J
authors: Zwerina
authors: Olivier
authors: O
authors: Harari
authors: John H
authors: JH
authors: Stone
references: Arthritis Rheum. 1994 Oct;37(10):1539-47
references: 7864947
references: Ann Rheum Dis. 2010 Jan;69(1):88-96
references: 19297346
references: Arthritis Rheum. 2000 May;43(5):1041-8
references: 10817557
references: Clin Exp Rheumatol. 2001 Sep-Oct;19(5):495-501
references: 11579707
references: N Engl J Med. 2009 Aug 27;361(9):888-98
references: 19710487
references: Rheumatology (Oxford). 2012 Jan;51(1):151-6
references: 22075063
references: Lancet. 2008 Mar 22;371(9617):987-97
references: 18358926
references: J Clin Invest. 1997 Jun 15;99(12):2842-50
references: 9185506
references: Clin Rev Allergy Immunol. 2008 Oct;35(1-2):88-95
references: 18286386
references: Arthritis Rheum. 2004 Apr 15;51(2):264-8
references: 15077270
references: Ann Rheum Dis. 2013 Sep 1;72(9):1481-7
references: 22993227
references: Curr Opin Rheumatol. 2011 Jan;23(1):43-9
references: 20827207
references: Proc Natl Acad Sci U S A. 2008 Nov 25;105(47):18460-5
references: 19015529
references: J Rheumatol. 2011 Sep;38(9):2080-1
references: 21885526
references: Joint Bone Spine. 2012 May;79(3):317-8
references: 22284606
references: Proc Natl Acad Sci U S A. 2008 Jul 1;105(26):9041-6
references: 18577591
references: Ann Rheum Dis. 2008 Nov;67(11):1516-23
references: 18625622
references: Clin Rheumatol. 2012 Aug;31(8):1263-5
references: 22661052
references: Nat Rev Immunol. 2010 Jul;10(7):490-500
references: 20559327
references: J Vasc Surg. 2008 Oct;48(4):1025-31
references: 18639414
references: Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9
references: 22674883
references: J Clin Invest. 1994 Sep;94(3):1134-40
references: 8083354
references: Arthritis Rheum. 2002 May;46(5):1309-18
references: 12115238
references: Ann Intern Med. 1994 Oct 1;121(7):484-91
references: 8067646
references: N Engl J Med. 2002 Jul 25;347(4):261-71
references: 12140303
references: Rheumatol Int. 2013 Nov;33(11):2961-2
references: 22965672
references: Hum Immunol. 1994 Jan;39(1):17-24
references: 8181959
references: Arthritis Rheum. 2008 Oct;58(10):2968-80
references: 18821691
references: Swiss Med Wkly. 2011 Jan 17;141:w13156
references: 21243547
references: Arthritis Rheum. 2003 Oct 15;49(5):703-8
references: 14558057
references: Ann Intern Med. 2003 Sep 16;139(6):505-15
references: 13679329
references: Medicine (Baltimore). 2011 May;90(3):186-193
references: 21512412
references: Arthritis Rheum. 2012 Nov;64(11):3788-98
references: 22833233
references: Invest Ophthalmol Vis Sci. 2011 May 17;52(6):3264-71
references: 21330657
references: Arthritis Rheum. 2009 Oct 15;61(10):1454-61
references: 19790127
references: Curr Opin Rheumatol. 2009 Jan;21(1):19-28
references: 19077714
references: Arthritis Rheum. 1990 Aug;33(8):1122-8
references: 2202311
references: Arthritis Rheum. 2008 Mar 15;59(3):422-30
references: 18311764
references: Arthritis Rheum. 2003 Dec;48(12):3532-7
references: 14674005
references: Arthritis Rheum. 2008 Jan;58(1):26-35
references: 18163497
references: Ann Intern Med. 2001 Jan 16;134(2):106-14
references: 11177313
references: Circulation. 2010 Feb 23;121(7):906-15
references: 20142449
references: Ann Rheum Dis. 1986 Feb;45(2):136-8
references: 3511861
references: Arthritis Rheum. 2008 Dec;58(12):3710-9
references: 19035481
references: Semin Arthritis Rheum. 2007 Aug;37(1):13-9
references: 17360027
references: Arthritis Rheum. 2012 Jun;64(6):2001-11
references: 22147555
references: J Intern Med. 1992 Oct;232(4):373-5
references: 1402645
references: Curr Allergy Asthma Rep. 2008 Jul;8(4):323-30
references: 18606086
references: Rheumatology (Oxford). 2011 Nov;50(11):2061-70
references: 21873264
references: Arthritis Care Res (Hoboken). 2010 Jun;62(6):835-41
references: 20535794
references: Arthritis Res. 2002;4 Suppl 3:S233-42
references: 12110143
references: Semin Arthritis Rheum. 1995 Jun;24(6):422-31
references: 7667646
references: Ann Rheum Dis. 2008 May;67(5):625-30
references: 18086726
references: Br J Rheumatol. 1990 Dec;29(6):456-8
references: 2124160
references: Ann Rheum Dis. 2011 Oct;70(10):1874-5
references: 21515917
references: Ann Rheum Dis. 2009 Mar;68(3):318-23
references: 18413441
references: Case Rep Rheumatol. 2012;2012:639612
references: 22937454
references: Medicine (Baltimore). 2004 Nov;83(6):335-341
references: 15525845
references: Ann Intern Med. 2007 May 1;146(9):621-30
references: 17470830
references: Arthritis Rheum. 1993 Sep;36(9):1286-94
references: 8216422
references: Br J Rheumatol. 1998 Apr;37(4):464-5
references: 9619904
references: Rheumatology (Oxford). 2010 Aug;49(8):1594-7
references: 20371504