NCT02534896终止3 期
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 20
- 主要终点
- Good/Moderate European League Against Rheumatism Responders
研究概览
简要总结
This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects able and willing to give written informed consent and is available for entire study.
- •Male or female ≥ 18 years old
- •Willing and able to comply with the study protocol visits, assessments and accessible for follow up
- •Known Diagnosed Rheumatoid arthritis
- •Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator
排除标准
- •Subjects who are pregnant or intend to become pregnant during the study
- •Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody.
- •Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents.
- •Active infection requiring systemic treatment
- •Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
研究组 & 干预措施
Treatment 1: Sunpharma1505 (Low dose) and Placebo
Experimental
干预措施: Treatment I (Drug)
Treatment II: Sunpharma1505 (High Dose) and Placebo
Experimental
干预措施: Treatment II (Drug)
Treatment III: Reference1505 and Placebo
Active Comparator
干预措施: Treatment III (Drug)
结局指标
主要结局
Good/Moderate European League Against Rheumatism Responders
时间窗: week 1
次要结局
- Good European League Against Rheumatism -Responders(Day 8)
- Good/Moderate European League Against Rheumatism Responders(Day 15)
- Good European League Against Rheumatism Responders(Day 15)
研究者
研究点 (20)
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