Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial, ADEM2 study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 8
- 主要终点
- Structural damage is assessed using the Verbruggen-Veys score. The evolution of structural damage between M0 and M12, or worsening, of digital osteoarthritis of a joint will be defined by the change in stage of the Verbruggen-Veys score by at least one level
研究概览
简要总结
Compare the efficacy of subcutaneous Methotrexate 15mg/week vs. placebo on the evolution of the disease. joint structure at 12 months in patients with erosive digital osteoarthritis
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 85
- •Digital osteoarthritis (IPD and IPP) according to ACR criteria (with a hand X-ray less than 3 months old, showing at least 3 joints with digital osteoarthritis KL>=2) and symptomatic for more than three months
- •At least one radiographically confirmed erosive hand joint with a pain VAS (patient) greater than 40 according to OARSI criteria
- •Presence of at least one active synovitis on B-mode ultrasonography
排除标准
- •Injection of hyaluronic acid within the last 6 months
- •Pregnant or breast-feeding women (a urine pregnancy test will be carried out in women of childbearing age
- •Injection of cortisone derivatives within the previous 3 months
- •Presence of psoriasis
- •Inflammatory rheumatism
- •Contraindications to the use of methotrexate
结局指标
主要结局
Structural damage is assessed using the Verbruggen-Veys score. The evolution of structural damage between M0 and M12, or worsening, of digital osteoarthritis of a joint will be defined by the change in stage of the Verbruggen-Veys score by at least one level
Structural damage is assessed using the Verbruggen-Veys score. The evolution of structural damage between M0 and M12, or worsening, of digital osteoarthritis of a joint will be defined by the change in stage of the Verbruggen-Veys score by at least one level
次要结局
未报告次要终点
研究者
Dr ALLAM
Scientific
Centre Hospitalier Universitaire De Nice