NCT00545454已完成2 期
Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Change from baseline in mean C-Reactive Protein level
研究概览
简要总结
The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).
The secondary objectives are:
- to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration;
- to assess the effect on pain relief within first 14 days;
- to obtain evidence of the safety and tolerability of SSR150106;
- to document trough plasma levels of SSR150106 and its first metabolite.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy
- •At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
- •C-Reactive Protein >=1.8 mg/dl confirmed during screening period
- •Non-poor Cytochrome P2D6 metabolizer status
排除标准
- •Functional Rheumatoid Arthritis class IV
- •Infections with hepatitis B, or C, or HIV
- •Presence or history (<5 years) of cancer
- •Manifest or latent tuberculosis
- •Functional abnormalities (including laboratory values) judged as clinically relevant
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
SSR150106 OEQD
Experimental
90 micro grams oral solution once every other day (OEQD)
干预措施: SSR150106 (Drug)
Placebo
Placebo Comparator
oral solution QD or OEQD
干预措施: Placebos (Drug)
SSR150106 QD
Experimental
90 micro grams oral solution once daily (QD)
干预措施: SSR150106 (Drug)
结局指标
主要结局
Change from baseline in mean C-Reactive Protein level
时间窗: end of the 4-week double-blind treatment period
次要结局
- C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels(at all time points measured)
- Improvement responder rates based on the American College of Rheumatology criteria(at all time points measured)
- Pain relief (change from baseline)(until day 14)
- Safety and tolerability(During the entire study patient's participation)
- Plasma levels of SSR150106 and its first metabolite(On a weekly basis during treatment phase, except at the end of the 3rd week)
研究者
研究点 (1)
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