Unizony Sebastian H, Dasgupta Bhaskar, Fisheleva Elena, Rowell Lucy, Schett Georg, Spiera Robert, Zwerina Jochen, Harari Olivier, Stone John H
Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.
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.
概述。GiACTA试验是一项多中心、随机、双盲、安慰剂对照研究，旨在测试白细胞介素（IL）-6受体拮抗剂托珠单抗（TCZ）维持巨细胞动脉炎（GCA）患者疾病缓解的能力。设计。约100个中心将招募250例活动性疾病患者。该试验包括一个为期52周的盲法治疗阶段，随后是104周的开放标签扩展阶段。患者将被随机分为四组。A组（每周162毫克TCZ加6个月泼尼松减量）；B组（每两周162毫克TCZ加6个月泼尼松减量）；C组（安慰剂加6个月泼尼松减量）；D组（安慰剂加12个月泼尼松减量）。我们假设，与仅接受6个月泼尼松疗程的患者相比，除接受6个月泼尼松疗程外还接受TCZ治疗的患者在52周时更有可能达到持续缓解（SR）的主要疗效终点，从而有可能将皮质类固醇的长期不良反应降至最低。结论。GiACTA将检验干扰IL-6信号传导对GCA患者产生有益影响的假设。本文的目的是描述该试验的设计并解决与其开展相关的主要问题。
