EUCTR2011-005634-19-PL进行中（未招募）不适用
A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
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
- •A diagnosis of adult onset RA in line with the protocol
- •Moderately active disease in line with the protocol
- •A pre-defined number of swollen joints in line with the protocol
- •Inadequate response to one or more conventional DMARDs
- •No evidence of respiratory disease
- •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 252
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement
- •secondary to RA
- •A history of, or current, inflammatory joint disease other than RA
- •Previous treatment with the investigational drug
- •Discontinuation of a biologic DMARD due to lack of efficacy.
- •Non-compliant concurrent medications
- •Non-compliance with medical history criteria
- •Subjects with chronic active hepatitis B as defined in protocol
研究者
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