EUCTR2012-004339-21-PL进行中（未招募）1 期
A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy - SARIL-RA-EASY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Diagnosis of rheumatoid arthritis (RA), =3 months disease duration
- •Patient willing and able to self-inject
- •Continuous treatment with 1 or a combination of nonbiologic DMARDs (except leflunomide in combination with methotrexate)
- •Moderate-to-severely active RA defined as: = 4/66 swollen and ….
- •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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients<18 years
- •Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists
- •Treatment with tumor necrosis factor (TNF) antagonists
- •Treatment with RA-directed biologic agents other than with a TNFa antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent
- •Prior treatment with a Janus kinase inhibitor
研究者
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