Methorexate and Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA.
128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores.
Keywords:
methotrexate knee osteoarthritis inflammation pain reduction physical funtion
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary knee osteoarthritis
- •synovitis
排除标准
- •other inflammatory conditions
- •hepatic insufficiency
- •renal insufficiency
研究组 & 干预措施
Methotrexate
25mg oral MTX tablets
干预措施: 25 mg/week oral methotrexate tablets (Drug)
Placebo
25 mg/week placebo tablets
干预措施: 25mg/week oral placebo tablets (Drug)
结局指标
主要结局
Pain reduction
时间窗: 8 months
The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).
次要结局
- Physical function improvement(8 months)
研究者
Anna Abou-Raya
MD
University of Alexandria