NCT00209859已完成4 期
Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ACR20 response
研究概览
简要总结
To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.
详细描述
Design: Multicentre, prospective, randomised, double-blind study with parallel design.
Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Synovitis in at least 2 joints.
- •Compliance with the ACR criteria for RA.
- •Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
- •Informed consent.
排除标准
- •Age less than 18 years or more than 75 years
- •Lack of co-operability.
- •Previous treatment with DMARD
- •Corticosteroid treatment during the preceding 4 weeks.
- •Contra indications for the treatments (awaiting the recommendations from Novartis)
- •Previous or present malignant or premalignant disease
- •Poorly regulated hypertension
- •Impaired renal function
- •Immuno defective diseases, including HIV
- •Cardiac or pulmonary insufficiency
- •Serious arteriosclerosis
- •Serious granulocytopenia or thrombocytopenia
- •Impaired liver function (liver enzymes more than twice the highest normal limit).
- •Alcohol consumption of more than 3 drinks a week.
- •Poorly controlled epilepsy
- •Lack of contraception in fertile patients
- •Pregnancy and lactation
- •Psoriasis
- •Poorly regulated diabetes
- •Anticoagulant treatment
- •Known allergy to the medicine
- •Medicamental interactions
- •Other inflammatory rheumatic diseases
研究组 & 干预措施
未命名试验
干预措施: Cyclosporine/placebo-cyclosporine (Drug)
未命名试验
干预措施: Intraarticular betamethasone (Drug)
未命名试验
干预措施: Methotrexate (Drug)
结局指标
主要结局
ACR20 response
次要结局
- ACR remission (modified)
- Cumulated dose of glucocorticoids
- Development of erosions
- Development of osteopenia
研究者
研究点 (1)
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