jRCT2080224869已完成3 期
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra(R)) in Adults with Dermatomyositis (DM) - The RECLAIIM Study (RECLAIIM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Responder rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Placebo-controlled, randomized, double blind, 2-arm parallel
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female subjects >= 18 years of age with diagnosis of at least probable idiopathic inflammatory myopathies per European League Against
- •Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of DM rash/manifestation, disease activity defined by presence of DM rash/manifestation or an objective disease activity measure, and disease severity defined by Physician Global Visual Analog Scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and Manual Muscle Test (MMT)-8 <= 142 or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score >= 14.
排除标准
- •Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage >= 3, or clinically relevant improvement between Screening Visit and Baseline
结局指标
主要结局
Responder rate
时间窗: Weeks 17, 21, and 25
A responder is defined as a subject with a TIS >= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or Week 21), who completes 24 weeks of randomized investigational medicinal product treatment without the use of rescue corticosteroid treatment. The TIS is a sum response criterion which incorporates 6 weighted International Myositis Assessment and Clinical Studies (IMACS) core set measures (CSMs). Thresholds for minimal, moderate, and major improvement were >= 20, >= 40, and >= 60 points on the TIS.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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