[Translation] A Phase III, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of subcutaneous belimumab in adult patients with connective tissue disease (CTD)-related interstitial lung disease (ILD)
主要目的:
评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者肺容量下降方面的有效性。 关键次要目的:
评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者肺容量下降%预测值方面的有效性。 评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者ILD进展方面的有效性。 评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比对CTD-ILD受试者疲劳的作用。 评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减轻CTD-ILD受试者症状严重程度方面的作用
[Translation] Primary objectives:
To evaluate the effectiveness of belimumab + standard therapy compared with placebo + standard therapy in slowing the decline in lung volume in CTD-ILD subjects. Key secondary objectives:
To evaluate the effectiveness of belimumab + standard therapy compared with placebo + standard therapy in slowing the % predicted decline in lung volume in CTD-ILD subjects. To evaluate the effectiveness of belimumab + standard therapy compared with placebo + standard therapy in slowing the progression of ILD in CTD-ILD subjects. To evaluate the effect of belimumab + standard therapy compared with placebo + standard therapy on fatigue in CTD-ILD subjects. To evaluate the effect of belimumab + standard therapy compared with placebo + standard therapy in reducing the severity of symptoms in CTD-ILD subjects.