Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments: A Randomised, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Structural lesion
研究概览
简要总结
Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Digital osteoarthritis (IPD and IPP) according to ACR criteria (with an X-ray of the hands taken less than 3 months ago, showing at least 3 joints with digital osteoarthritis KL>=2) and symptomatic for more than three months
排除标准
- •Having a bilirubin level > 5 mg/dl (85.5 µmol/l)
- •Pregnant or breastfeeding women (a urine pregnancy test will be performed on women of childbearing age),
- •Injection of hyaluronic acid within the previous 6 months,
- •Injection of cortisone derivatives within the previous 3 months,
- •Presence of psoriasis,
- •Inflammatory rheumatism,
- •Microcrystalline arthropathy,
- •Joint prosthesis in one of the joints of the hand,
- •Planned placement of a joint prosthesis in the hand during the study period,
- •Major progressive disease (life-threatening cardiovascular disease, hematopoietic cancers including myeloma, cancers with risk of bone metastases),
- •Liver failure.
- •Severe renal failure (creatinine clearance less than 50 ml/min).
- •Positive hepatitis B serology.
- •Tuberculosis, hepatitis C, HIV positive, or other immunodeficiency syndromes.
- •Uncontrolled infections.
- •Use of corticosteroids.
- •Use of morphine derivatives,
- •Taking Bactrim,
- •Taking high doses of aspirin (greater than or equal to 500mg/day),
- •Contraindications to the use of methotrexate,
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Methotrexate injectable
干预措施: Methotrexate Injectable Solution (Drug)
结局指标
主要结局
Structural lesion
时间窗: 12 months
The progression of structural damage between M0 and M12, the worsening of digital osteoarthritis in a joint, will be defined by the change in stage of the Verbruggen-Veys score. The Verbruggen-Veys anatomical scoring system for hand osteoarthritis, which evaluates the radiographic progression of interphalangeal joints. This scale classifies each joint into five stages (N, S, J, E, R) reflecting increasing severity of structural damage. Progression is defined as a transition to a more advanced stage between M0 and M12. As this is a categorical ordinal scale rather than a continuous numerical score, there are no minimum or maximum numerical values. However, higher stages correspond to more severe structural damage and thus a worse outcome.
次要结局
- Function(12 months)
- Effectiveness of the treatment on pain(12 months)