Design of the Tocilizumab in Giant Cell Arteritis Trial

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Design of the Tocilizumab in Giant Cell Arteritis Trial

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Title: Design of the Tocilizumab in Giant Cell Arteritis Trial
Author: Unizony, Sebastian; Dasgupta, Bhaskar; Fisheleva, Elena; Rowell, Lucy; Schett, Georg; Spiera, Robert; Zwerina, Jochen; Harari, Olivier; Stone, John H

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Citation: Unizony, Sebastian H., Bhaskar Dasgupta, Elena Fisheleva, Lucy Rowell, Georg Schett, Robert Spiera, Jochen Zwerina, Olivier Harari, and John H. Stone. 2013. Design of the tocilizumab in giant cell arteritis trial. International Journal of Rheumatology 2013:912562.
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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.
Published Version: doi:10.1155/2013/912562
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