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International Journal of Rheumatology
Volume 2013 (2013), Article ID 912562, 10 pages
http://dx.doi.org/10.1155/2013/912562
Clinical Study

Design of the Tocilizumab in Giant Cell Arteritis Trial

1Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA
2Southend Hospital, Westcliff-on-Sea, Essex, SS0 0RY, UK
3Hoffmann-LaRoche Pharmaceuticals Inc., Shire Park, Welwyn Garden City AL7 1TW, UK
4University of Erlangen-Nuremberg, Krankenhausstrasse 12, 91054 Erlangen, Germany
5Hospital for Special Surgery, Cornell, New York, NY 10021, USA

Received 7 December 2012; Accepted 12 February 2013

Academic Editor: Ruben Burgos-Vargas

Copyright © 2013 Sebastian H. Unizony et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.