EUCTR2013-002773-21-GB进行中（未招募）1 期
A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 279
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female of =18 years of age, who provide written informed consent at screening - SLEDAI-2K score =6 at screening- Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification criteria for SLE during the course of their illness at screening - Disease duration of at least 6 months from the time of diagnosis (when the subject met at least 4 of the ACR criteria) at screening - Positive test results for ANA (human epithelial cell [Hep]-2 ANA = or >1:80) and/or anti-dsDNA antibody (=30 IU/mL) at screening - Other protocol defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •- History or current diagnosis of any demyelinating disease
- •- Active central nervous system SLE deemed to be severe or progressive
- •- Use of cyclophosphamide within 3 months before or during SV
- •- Active, moderate to severe glomerulonephritis and/or severe renal impairment (spot urine protein:creatinine ratio [UPCr] =2 mg/mg
- •-Other protocol defined exclusion criteria may apply
研究者
相似试验
进行中（未招募）
1 期
Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)Systemic Lupus Erythematosus (SLE)MedDRA version: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-002773-21-CZMerck KGaA279
进行中（未招募）
1 期
Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)Systemic Lupus Erythematosus (SLE)MedDRA version: 16.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-002773-21-ESMerck KGaA279
进行中（未招募）
1 期
Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)Systemic Lupus Erythematosus (SLE)MedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-002773-21-DEMerck KGaA279
进行中（未招募）
1 期
Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)Systemic Lupus Erythematosus (SLE)MedDRA version: 16.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2013-002773-21-ITMerck KGaA279
进行中（未招募）
不适用
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid ArthritisMedDRA version: 17.1Level: LLTClassification code 10066578Term: Progression of rheumatoid arthritisSystem Organ Class: 100000004859MedDRA version: 17.1Level: LLTClassification code 10060732Term: Rheumatoid arthritis flare upSystem Organ Class: 100000004859Rheumatoid ArthritisEUCTR2013-003780-65-HUBristol-Myers Squibb International Corporation230