[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial evaluating the efficacy and safety of ARD-885 in patients with moderate to severe active rheumatoid arthritis.
主要目的
评价ARD-885用于中至重度活动性类风湿关节炎患者的有效性;
评价ARD-885用于中至重度活动性类风湿关节炎患者时剂量与疗效之间的关系(仅适用于IIb期)。
次要目的
评价ARD-885用于中至重度活动性类风湿关节炎患者的安全性;
评价ARD-885对中至重度活动性类风湿关节炎患者外周血中相关炎性生物标志物表达的影响;
评价ARD-885在中至重度活动性类风湿关节炎患者中的群体药代动力学特征。
[Translation] Primary Objectives:
Evaluate the efficacy of ARD-885 in patients with moderate to severe active rheumatoid arthritis (RA);
Evaluate the dose-efficacy relationship of ARD-885 in patients with moderate to severe active RA (Phase IIb only).
Secondary Objectives:
Evaluate the safety of ARD-885 in patients with moderate to severe active RA;
Evaluate the effect of ARD-885 on the expression of relevant inflammatory biomarkers in peripheral blood of patients with moderate to severe active RA;
Evaluate the population pharmacokinetic characteristics of ARD-885 in patients with moderate to severe active RA.