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Design of the Tocilizumab in Giant Cell Arteritis Trial.
- Source :
- International Journal of Rheumatology; 2013, p1-10, 10p
- Publication Year :
- 2013
-
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 162mg weekly plus a 6-month prednisone-taper); group B (TCZ 162mg 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- GIANT cell arteritis
POLYMYALGIA rheumatica
PLACEBOS
DRUGS
BEHAVIORAL medicine
Subjects
Details
- Language :
- English
- ISSN :
- 16879260
- Database :
- Complementary Index
- Journal :
- International Journal of Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 95276253
- Full Text :
- https://doi.org/10.1155/2013/912562