NCT01274182已完成1 期
A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 312
- 试验地点
- 76
- 主要终点
- AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
研究概览
简要总结
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Rituxan
Active Comparator
干预措施: Rituxan (Biological)
MabThera
Active Comparator
干预措施: MabThera (Biological)
GP2013
Experimental
干预措施: GP2013 (Biological)
结局指标
主要结局
AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
时间窗: From baseline to 24 weeks
Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169
次要结局
- Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA(From baseline to week 24)
- Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA(14 days)
- Change From Baseline in DAS28(CRP) at Week 24(24 weeks)
- Number of Patients With ACR20 (CRP) Response(24 weeks)
- Summary of Disease Activity According to CDAI(At week 24)
- Participant Response as Assessed by EULAR Response Criteria(At week 24)
- Summary of Disease Activity According to SDAI(At week 24)
研究者
研究点 (76)
Loading locations...
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