NCT01567358已完成1 期
A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Safety : Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with 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
- •Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
- •Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit
排除标准
- •History of following diseases
- •Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
- •Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
- •Severe infectious disease（hepatitis, pneumonia、sepsis）
- •History of demyelinating disease or multiple sclerosis
- •Congestive heart failure
- •lymphoproliferative disorder or myelodysplastic syndrome
- •History of malignancy
- •Interstitial lung disease
- •Patients with active or latent tuberculosis or history of tuberculosis
研究组 & 干预措施
Remicade
Active Comparator
干预措施: Infliximab (Biological)
NI-071
Experimental
干预措施: Infliximab (Biological)
结局指标
主要结局
Safety : Incidence of Adverse Events
时间窗: 14 weeks
次要结局
- PK : Area under the serum concentration versus time curve(AUC)(14 weeks)
- Efficacy : ACR core-set(14 weeks)
研究者
研究点 (1)
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