JPRN-jRCT2080224869招募中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
- 招募中
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)MedDRA version: 20.0Level: LLTClassification code 10001403Term: Adult dermatomyositisSystem Organ Class: 100000004858DermatomyositisEUCTR2018-003171-35-DECSL Behring LLC126
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)MedDRA version: 20.0Level: LLTClassification code 10001403Term: Adult dermatomyositisSystem Organ Class: 100000004858DermatomyositisEUCTR2018-003171-35-HUCSL Behring LLC126
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)MedDRA version: 20.0Level: LLTClassification code 10001403Term: Adult dermatomyositisSystem Organ Class: 100000004858DermatomyositisEUCTR2018-003171-35-ITCSL BEHRING GMBH126
已完成
3 期
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - The RECLAIIM StudydermatomyositisNL-OMON55228CSL Behring LLC
进行中（未招募）
1 期
A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)DermatomyositisEUCTR2018-003171-35-FRCSL Behring LLC126