Design of the Tocilizumab in Giant Cell Arteritis Trial. (7th April 2013)

• Record Type: Journal Article
• Authors: Unizony, Sebastian H.; Dasgupta, Bhaskar; Fisheleva, Elena; Rowell, Lucy; Schett, Georg; Spiera, Robert; Zwerina, Jochen; Harari, Olivier; Stone, John H.
• Other Names: Burgos-Vargas Ruben Academic Editor.
• Is Part Of: International journal of rheumatology. Volume 2013(2013)
• Publication Date: 2013-04-07
• Subjects: Rheumatology -- Periodicals; Rheumatology; Rheumatology; Electronic journals; Periodicals; Periodicals; 616.723
• DOI: 10.1155/2013/912562
• Languages: English
• ISSNs: 1687-9260

Abstract

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.