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临床试验/NCT01654575
NCT01654575已完成不适用

Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

University of Alexandria1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

25mg/week orally

干预措施: Methotrexate (Drug)

Placebo

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Abou-Raya

Professor of Rheumatology

University of Alexandria

研究点 (1)

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