A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Scios, Inc.
- 入组人数
- 302
- 主要终点
- ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
研究概览
简要总结
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).
详细描述
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
- •Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study
排除标准
- •Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
- •Lab tests revealed elevated liver enzymes within the past 6 months
- •Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
- •HIV positive
- •Abnormal electrocardiogram
- •Chronic or acute infection
研究组 & 干预措施
001
SCIO-469 30 mg capsule three times daily for 12 weeks
干预措施: SCIO-469 (Drug)
002
SCIO-469 60 mg capsule three times daily for 12 weeks
干预措施: SCIO-469 (Drug)
003
SCIO-469 100 mg tablet once daily for 12 weeks
干预措施: SCIO-469 (Drug)
004
Placebo 2 capsules three times daily and one tablet daily
干预措施: Placebo (Drug)
结局指标
主要结局
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
时间窗: Day 1 to approximately Day 85 of treatment
次要结局
- ACR50 responders at Week 12(12 weeks)
- ACR20 and ACR50 responders at each evaluation visit other than Week 12(24 weeks)
- All individual variables of the ACR response criteria at each evaluation visit(24 weeks)
- Disease Activity Score (DAS)28 at each evaluation visit.(24 Weeks)
- The number of participants experiencing adverse events (AEs) as a measure of safety(24 weeks)