Design of the Tocilizumab in Giant Cell Arteritis Trial

الملخص EN

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.