Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary knee osteoarthritis
- •pain not responding to the usual therapy
- •synovitis
排除标准
- •any other inflammatory conditions,
- •hepatic and renal insufficiency
研究组 & 干预措施
Methotrexate
25mg/week orally
干预措施: Methotrexate (Drug)
Placebo
Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain reduction
时间窗: 16 weeks
次要结局
- Improvement in physical function scores(4 months)
研究者
Anna Abou-Raya
Professor of Rheumatology
University of Alexandria
