Available datapackage for study 'Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus'

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

本研究为一项II/III期随机、双盲、安慰剂对照多中心临床试验，旨在评估利妥昔单抗（rituximab）联合单一稳定背景免疫抑制药物时，与安慰剂联合该方案相比，对中度至重度系统性红斑狼疮（systemic lupus erythematosus, SLE）受试者的疗效与安全性。本试验的主要疗效终点将在52周时进行评估。