EUCTR2010-021184-32-IT进行中（未招募）1 期
A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hexal AG
- 入组人数
- 164
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
- •Rheumatoid arthritis as defined by the 1987 ACR classification
- •Severe active seropositive disease
- •Inadequate response or intolerance to other DMARDs and anti-TNFs
- •Treatment with Methotrexate
- •For additional inclusion criteria, please refer to section 4.1 of the protocol.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •Patients with systemic manifestations of rheumatoid arthritis
- •Female patients nursing
- •Women of childbearing potential unless using birth control
- •Active infection
- •Known immunodeficiency syndrome
- •Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- •History of cancer
- •For additional exclusion criteria, please refer to section 4.2 of the protocol.
研究者
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