NCT01927263已完成3 期
A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Efficacy : Changes in DAS28-ESR
研究概览
简要总结
The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
- •Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
排除标准
- •Patients with a following past History or concomitant diseases
- •Other Connective tissue disorders which may interfere the efficacy assessment
- •Chronic or recurrent infectious disease
- •Demyelinating disease
- •Congestive heart failure
- •lymphoproliferative disorder or myelodysplastic syndrome
- •Malignancy
- •Interstitial lung disease
- •Patients with active or latent tuberculosis or history of tuberculosis
结局指标
主要结局
Efficacy : Changes in DAS28-ESR
时间窗: week 0 to week 14
次要结局
- Efficacy : Changes in DAS28(week 0 to week 54)
- Efficacy : Changes in ACR20, 50, 70(week 0 to week 54)
- Efficacy : Changes in ACR core-set(week 0 to week 54)
- Safety : Long term safety (Adverse Events, Immunogenicity, etc.)(to 54 weeks)
研究者
研究点 (2)
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