Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change of Pain Score
研究概览
简要总结
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.
详细描述
Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A clinical diagnosis of ankylosing spondylitis (AS) by treating rheumatologists, or a diagnosis of axial spondyloarthritis (axSpA) with a pelvis MRI with significant bone marrow edema on STIR sequences;
- •Minimum of 18 years old;
- •Are taking NSAIDs on a regular basis for AS or axSpA (defined as more than 20 days in the past month) and willing to withhold medication for one week; or having active symptoms that require initiation of NSAIDs;
- •Concomitant anti-rheumatic drugs are allowed, if the dose has been stable for the past three months;
- •Have active disease after initial washout period, defined by BASDAI >=4/10, or back pain numerical rating scale (NRS)>=4/10
排除标准
- •Patients who have concurrent rheumatic diseases other than AS or axSpA;
- •Patients who have oral corticosteroid in the past two weeks; patients who have acute peripheral arthritis;
- •Patients with a fibromyalgia score >= 13;
- •Patient with extensive cardiac history, history of gastrointestinal bleeding that required blood transfusion, chronic kidney diseases, abnormal liver function tests; or female patients who are pregnant.
- •Use of low-dose of aspirin (<100mg daily) is allowed in the study.
研究组 & 干预措施
Indomethacin
Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
干预措施: Indomethacin (Drug)
Diclofenac
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
干预措施: Diclofenac (Drug)
Meloxicam
Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
干预措施: Meloxicam (Drug)
Celecoxib
Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
干预措施: Celecoxib (Drug)
结局指标
主要结局
Change of Pain Score
时间窗: Baseline, Week 4, and Week 6
Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
次要结局
- Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Week 4, and Week 6)
- Change of Bath Ankylosing Spondylitis Function Index (BASFI)(Baseline, Week 4, and Week 6)
- Change of ASAS Endorsed Disease Activity Score (ASDAS)(Baseline, Week 4, and Week 6)
- Patient Global Assessment of Response to Therapy (PGART)(Week 6)
研究者
Runsheng Wang, MD, MHS
Instructor in Medicine
Columbia University