A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Synovial Blood Flow
研究概览
简要总结
The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.
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
- •Patient is willing to limit alcohol intake to 3 or less beverages per day
- •Patient agrees to use only acetaminophen/paracetamol for breakthrough pain
排除标准
- •Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks
- •Patient has a history of drug or alcohol abuse in the last 2 years
- •Patient has had a vaccine (with a live or attenuated virus) in the last two weeks
研究组 & 干预措施
Prednisone 15 mg
Prednisone 15 mg tablets once daily for 15 days
干预措施: Prednisone 15 mg (Drug)
Placebo 15 mg
Prednisone 15 mg placebo tablets once daily for 15 days
干预措施: Placebo Tablets (Drug)
Prednisone 7.5 mg
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
干预措施: Prednisone 7.5 mg (Drug)
Placebo 7.5 mg
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
干预措施: Placebo Over-Encapsulated Tablets (Drug)
结局指标
主要结局
Synovial Blood Flow
时间窗: Baseline and Day 14
Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.
次要结局
- Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])(Baseline and Day 14)