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Design of the Tocilizumab in Giant Cell Arteritis Trial
Joint Authors
Schett, Georg
Stone, John H.
Zwerina, Jochen
Harari, Olivier
Fisheleva, Elena
Unizony, Sebastian H.
Rowell, Lucy
Dasgupta, Bhaskar
Spiera, Robert
Source
International Journal of Rheumatology
Issue
Vol. 2013, Issue 2013 (31 Dec. 2013), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2013-04-07
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract 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.
American Psychological Association (APA)
Unizony, Sebastian H.& Dasgupta, Bhaskar& Fisheleva, Elena& Rowell, Lucy& Schett, Georg& Spiera, Robert…[et al.]. 2013. Design of the Tocilizumab in Giant Cell Arteritis Trial. International Journal of Rheumatology،Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-507500
Modern Language Association (MLA)
Unizony, Sebastian H.…[et al.]. Design of the Tocilizumab in Giant Cell Arteritis Trial. International Journal of Rheumatology No. 2013 (2013), pp.1-10.
https://search.emarefa.net/detail/BIM-507500
American Medical Association (AMA)
Unizony, Sebastian H.& Dasgupta, Bhaskar& Fisheleva, Elena& Rowell, Lucy& Schett, Georg& Spiera, Robert…[et al.]. Design of the Tocilizumab in Giant Cell Arteritis Trial. International Journal of Rheumatology. 2013. Vol. 2013, no. 2013, pp.1-10.
https://search.emarefa.net/detail/BIM-507500
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-507500